162 Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 25.01.2023 2023-Jan-25 540 KB

Page 1 of 17 Rapid / CLIA/ ELISA Kits approved for testing of Covid-19

Date: 25.01.2023 S. No. Name of the Firm Type of Kit Country

1. M/s CPC Diag. Pvt. Ltd,Chennai ChemiLuminscentImmun o Assay IgG &IgM (CLIA) CE and Australia Approved M/s Shenzhen YHLO Biotech Co. Ltd.China
2. M/s. S.D. Biosensor Delhi Fluorescent Rapid Antigen Test M/s S.D. Biosensor, Korea CE Approved
3. M/s. TrivitronHealthcarePv tLtd, Chennai Chemi Luminescence Immuno Assay CLIA CE approved M/s Shenzhen New Industries Biomedical Engineering (SNIBE),China
4. M/s. SNIBE Diagnostics (India), Gurgaon Chemi Luminescence Immuno Assay CLIA CE approved M/s Shenzhen New Industries Biomedical Engineering (SNIBE),China
5. M/s. Vishat Diagnostics Pvt Ltd Mumbai ELISA CE approved M/s. Zhengzhou Human well Biocel Technology Ltd China
6. M/s. ImmunoshopIndia Pvt Ltd, Thane Chemi Luminescence Immuno Assay CLIA CE approved M/s. Shenzhen New Industries Biomedical Engineering (SNIBE),China
7. M/s.Athenese Dx Pvt Ltd, Chennai Rapid Antibody test IgG/IgMCE approved M/s Beijing Genese Biotech Inc , China
8. M/s. Indelox Global Distribution, PvtLtd, Bangalore Antibody test IgG/IgM CE approved M/s. Dongguan Bosh Biotechnology, China
9. M/s. Rapid Diagnostics Pvt Ltd Delhi CE approved M/s Hangzhou Biotech Co Ltd, China
10. M/s PTS Diagnostics India Pvt. Ltd. CE approved M/s Changsha Sinocare Inc China
11. M/s. AccrediatedConsultan tPvtLtd CE approved M/s. Humasis Co Ltd Korea
12. M/s. AgappeDiagnosticsLt d CE approved

M/s Hangzhou Biotech Co Ltd, China 13. M/s. Rafael Diagnostics, Pune Antibody test IgG/IgM CE approved M/s. BMT Diagnostics Israel 14. M/s. Matrix Lab Chennai CLIACE Approved M/s. Autobio Diagnostics Co Ltd China

Page 2 of 17 15. M/s. Voxtur Bio Ltd Indigenous 16.
M/s. Vanguard Diag Pvt Ltd Indigenous 17.
M/s. Weldon Biotech(I) Pvt.Ltd. iChromeFIA( FluoracenceImmunoAssay) Covid-19 Ab M/s Boditech Med Inc. Korea 18.
M/s HLL Indigenous
19.
M/s CPC Diagnostics Pvt. Ltd. Anti SAR- COV-2 ELISA IgG M/s Euroimmun AG Germany
20.
M/s Bravo Pharmaceuticals Pvt. Ltd. CE approved M/s Biosynex S.A
France
21.
M/s Harmony LifeSciences Pvt. Ltd.
CE approved M/s Humasis Co. Ltd.
South Korea 22.
M/s Trivitron Healthcare Pvt. Ltd. CE approved M/s Innovita(Tang Shen) Biological Technology Co. Ltd. China 23.
M/s Concept HealthCare CE approved M/s CeltexBiotech(Suzhou) Co. Ltd. China 24.
M/s Bio Innovations Thane
CE approved M/s Primer Design Ltd. U.K 25.
M/s AR KAY Medicos Pvt. Ltd. CE approved M/s Humasis Co. Ltd. South Korea 26.
M/s Kin Diagnostics
West Bengal FIA iChroma IgG/IgM CE approved M/s Boditech Med Inc. South Korea 27.
M/S Aracion Technology Pvt LTd

CE approved M/s Innovita(Tang Shen) Biological Technology Co. Ltd.China 28.
M/s. SD Bio Sensor Healthcare Pvt Ltd Standard Q COVID-19 IgG/IgM Duo Indigenous 29.
M/s. Tara Medicos Pvt Ltd Jaipur CE approved M/s. CELLEX INC,CHINA 30.
M/s Med Source Ozone Biomedicals Pvt Ltd COVID-19 IgG/IgM Rapid Test Indigenous 31.
M/s. Immunoscience IndiaPvt Ltd COVID-19 IgG/IgM Rapid Test Indigenous 32.
M/s S.D Biosensor Healthcare Pvt. Ltd. Standard Q Covid-19 IgG/IgM Combo M/s S.D Biosensor Inc. Korea 33.
M/s True Healthcare India Pvt. Ltd. CE approved M/s Humasis Co. Ltd. South Korea 34.
M/s Immunoshop India Pvt. Ltd. CE approved M/s Shenzhen Cifotrunic Technology Ltd. China

Page 3 of 17

M/s Clini Experts Services Pvt. Ltd. CE approved M/s Biocan Diagnostics Inc. Canada 36.
M/s Inbios India, Delhi Antibody test IgG/IgM
CE approved M/s. CELLEX Biotech (Suzhou) Co. Ltd ,CHINA 37.
M/s. Synergy Scientific Services Pvt Ltd CE approved M/s. Schenzhen Reagent Technology Co Ltd China 38.
M/s Bioscience Sales Corp. Delhi CE approved M/s. ShenzhanWatmind Medical Co. Ltd , China 39.
M/s. Doctor Analytical Laboratories Pvt Ltd CE approved M/s Biocan Diagnostics Inc. Canada 40.
M/s Alere Medical Pvt. Ltd. PanBioAntibody test IgG/IgMCE approved M/s Abbott Rapid Diagnostics Germany Having Mfg. Site at Abon Biopharma(Hangzhou) Co. Ltd. China
41.
M/s Incarp Instruments Pvt. Ltd. Hyderabad
FIA IgG/IgM AntiBody TestCE approved M/s Boditech Med Inc. South Korea 42.
M/s Nucleus 18Turnkey Projects Pvt. Ltd.Telangana Australian EUA
M/s Innovita (Tangshan) Biological Technology Co. Ltd. China 43.
M/s KDH Biomedicals Pvt Ltd Mumbai CE approved M/s Dynamiker Biotechnology (Tianjin) Co Ltd China 44.
M/s KDH Biomedicals Pvt Ltd Mumbai ELISA IgG and ELISA IgM/IgA CE approved M/s Dynamiker Biotechnology (Tianjin) Co Ltd China 45.
M/s Trivitron Healthcare Pvt LTD, Chennai. CE approved M/s Shenzhen Lifotronic Technology Co. Ltd. China

M/s Bioplus Healthcare Pvt Ltd, Bangalore CE approved M/s CellexBioTech (Suzhou) Co. Ltd. China
47.
M/s Alpine Biomedicals Pvt Ltd, Haryana Rapid Antibody test IgG/IgM

Indigenous 48.
M/s Abbott Healthcare Pvt Ltd Chemiluminescent Microparticle Immunoassay With Architect System M/s Abbott Ireland Diag Div. Ireland

M/s Lab Care Diag, India Pvt Ltd

Indigenous 50.
M/s.Nulife, Noida

Indigenous

Page 4 of 17 51.
M/s Tulip Diagnostics Pvt Ltd, Goa Coviscreen-Rapid Double Antigen test for detection of IgG/IgM/IgA Indigenous 52.
M/s Roche Diagnostics India Pvt. Ltd. Delhi ECLIA
Elecys Anti SARS COV2 M/s Roche Diagnostics GmbH, Germany
53.
M/s SidakLifeCare Pvt. Ltd. Indigenous 54.
M/s S.D Biosensor HealthCare Pvt. Ltd. Standard Q COVID-19 IgG/IgM Combo Indigenous 55.
M/s Diasorin Healthcare India Pvt. Ltd. CLIA
M/s Diasorin S.P.A, Itlay 56.
M/s Mindray Medical India Pvt. Ltd. Mumbai CLIA M/s Shenzhen Mindray, China 57.
M/s Ortho Clinical Ltd. Vitros Immunodiagnostic Total Reagent Pack M/s Ortho Clinical Diagnostics, USA 58.
M/s CliniExperts Services Pvt. Ltd M/s Europlaz Technologies, U.K 59.
M/s Cadila Healthcare Ltd. ELISA
Indigenous
60.
M/s McW Healthcare Pvt Ltd M/s TechnogeneticsS.r.l Italy 61.
M/s Omega Dx (Asia) Pvt Ltd ELISA M/s Genesis Diagnostics Ltd , UK 62.
M/s Abbott Healthcare Pvt Ltd CMIA M/s Abbott Ireland 63.
M/S Ortho Clinical Diag. India Pvt. Ltd CLIA, IgG qualitative immunodiagnostic assay kit M/S Ortho clinical Diag. UK 64.
M/s Ortho Clinical Diag.India Pvt. Ltd VITROS (Immunodiagnostics Assay Kit) including IgG,IgA and IgM M/s Ortho clinical Diag. UK 65.
M/s Tosoh India Pvt Ltd ELISA IgA, ELISA IgG, ELISA IgM M/s NovaTec GmbH, Germany 66.
M/s Biorad Laboratories (India) Pvt Ltd Platellia SARS-COV2 Total Ab M/s Biorad , France 67.
M/s Novomed Inc Pvt Ltd ELISA IgG/IgM M/s Ga Generic Assay GmbH Germany

Page 5 of 17 68.
M/s Ortho Clinical Diag.India Pvt. Ltd CLIA ,Vitros IgG M/s Ortho clinical Diag. UK 69.
M/s S D Biosensor Healthcare Pvt Ltd Standard Q COVID-19Ag Indigenous 70.
M/s. J. Mitra
COVID IgM+IgG+IgA Microlisa Indigenous 71.
M/s.Laj Exports Ltd Rapid IgG/IgM M/s. Biohit Healthcare (Hefei)Co Ltd China 72.
M/s Siemens Healthcare Pvt Ltd .ADVIA Centaur SARS- COV-2 (IgG/IgM) M/s Siemens Healthcare Diag. Inc USA 73.
.Atellica IM SARS-COV- 2(IgG/IgM) 74.
Dimension EXL SARS- COV-2(IgG/IgM) 75.
M/s Inbios India Detect IgG ELISA M/s Inbios International Inc, USA 76.
M/s SirusBiocare Pvt Ltd SCO-2IgG ELISA M/s Inbios International Inc, USA 77.
M/s Beckman Coulter India PVt Ltd Access SARS-COV-2 IgGCLIA M/s Beckman Coulter Ireland 78.
M/S Karwa Enterprises Pvt Ltd Karwa SARS CoV-2 IgG ELISA Indigenous
79.
M/s POCT Services Pvt Ltd One step Novel (COVID- 19) IgG antibody test Indigenous 80.
M/s SirusBiocare Pvt Ltd SCOV-2IgMELISA M/s Inbios International Inc, USA 81.
M/s Ubio Biotechnology Systems Pvt Ltd Covid IgG/IgM Rapid Indigenous 82.
M/s Trivitron Healthcare Pvt Ltd Covid Screen Plus ELISA kit IgG/IgM/IgA Indigenous 83.
M/s Inbios India SCOV-2Detect IgM ELISA M/s Inbios International Inc USA 84.
M/s Lab Care Diag. India Pvt Ltd COVID-19 Antigen Lateral Flow Test Device Indigenous 85.
M/s Vishat Diag. Pvt Ltd COVID-19 Ag Respi-Strip M/s CorisBioconcept, Belgium 86.
M/s Cadila Healthcare Ltd COV-2IgG Antibody detection ELISA (COVID KAVACH) Indigenous 87.
M/s Siemens Healthcare Pvt Ltd Atellica IM SARS-COV-2 IgG M/s Siemens Healthcare Diag. Inc USA

Page 6 of 17 88.
M/s J. Mitra &Co.Pvt Ltd COVID Kawach IgG Microlisa Indigenous 89.
M/S Biomerieux India Pvt Ltd VIDAS SARS-COV-2 IgM VIDAS SARS-COV-2 IgG

M/s Biomerieux SA France 90.
M/s Aspen Laboratories Pvt Ltd SARS-CoV-2 ELISA IgG Kit Indigenous 91.
M/s Trivitron Healthcare Pvt Ltd SARS-CoV-2 ELISA IgG Kit Indigenous 92.
M/s Voxtur Bio Ltd
Cov -2 IgG ELISA Indigenous 93.
M/s MerilDiag Pvt Ltd Covid -19 IgG/IgM rapid Indigenous 94.
M/s Oscar Medicare Pvt Ltd Antibody detection kit Indigenous 95.
M/s Diasure Immunodiagnostics Covid Rapid Test Cassette M/s Biopanda Reagents U.K 96.
M/s Immunoshop India Pvt Ltd SARS COV-2 Ab ELISA M/S Beijing Wantai Biological Pharmacy Enterprises Co. Ltd 97.
M/s Tulip Diag. Pvt Ltd Double Antigen Screening Test Indigenous 98.
M/sAthenese Dx Pvt Ltd Covid-19 Ab Rapid test Indigenous 99.
M/s Nulife Covid -19 IgG/IgM Antibody rapid test Indigenous 100. M/s Trivitron Healthcare Biocard Pro Covid-19 Antigen test Indigenous 101. M/s. Himedia Laboratories Pvt Ltd ELISA Antibody Test Kit for COVID-19 Detection Indigenous 102. M/s. POCT Services Private Limited Covid ELISA Test for the Detection of IgG Antibodies Indigenous

Page 7 of 17 103. M/s. MD Next Life Sciences LLP, New Delhi. SARS CoV 2 IgG/IgM Rapid Test Kit M/s TBG Biotech Corp, Taiwan 104. M/s Beckman Coulter India Private Limited, Chennai ACCESS SARS-CoV-2 IgM (CLIA) M/s Beckman Coulter Ireland Inc, Ireland 105. M/s Vishat Diagnostic Pvt Ltd, Pune GenBody COVID-19 Ag M/s GenBody Inc, South Korea. 106. M/s Angstrom Biotech Pvt. Ltd, Haryana COVID 19 ANTIGEN KIT Indigenous 107. M/s. Premier Medical Corporation Private Limited, Gujarat. COVID-19 IgG/IgM Card Test Indigenous 108. M/s. Premier Medical Corporation Private Limited, Gujarat. COVID-19 Antigen Card Test Indigenous 109. M/s Alere Medical Private Limited, Haryana Panbio SARS-CoV-2 IgG ELISA M/s Axis-Shield Diagnostics Ltd, UK 110. M/s Meril Diagnostics Private Limited, Gujarat COVID-19 Antigen Detection Test Kit Indigenous 111. M/s Thermo Fisher Scientific India Pvt. Ltd, Telangana COVID-19 Total Antibody ELISA Test M/s Fisher Diagnosticsa Division Of Fisher Scientific Company LLCa Part Of Thermo Fisher Scientific Inc, USA 112. M/s Oscar Medicare Private Limited, Delhi CORONA IgG ELISA Indigenous 113. M/s Ubio Biotechnology Systems Private Limited, Kerala. COVID-19 Ag Test Indigenous 114. M/s Fitcare Private Limited, Assam. COVID-19 Antigen Rapid Test M/s Genbody Inc, South Korea 115. M/s Deep Meditech Pvt. Ltd. Delhi PCL COVID19 Ag Rapid FIA M/s PCL, Inc, South Korea. 116. M/s Oscar Medicare Private Limited, Delhi Corona Antigen test Indigenous 117. M/s Alpine Biomedicals Private Limited, Haryana Alpine One Step Novel Coronavirus (COVID-19) Antigen Rapid Test Kit Indigenous

Page 8 of 17 118. M/s Advy Chemical Pvt Ltd, Mumbai EzDx Covid -19 IgG/IgM rapid antibody test for detection of IgG and IgM antibodies in human serum/plasma/Whole blood Indigenous 119. M/s Genuine Biosystem Private Limited, Chennai Covid-19 S1 RBD IgG ELISA kit
Indigenous 120. M/s Oscar Medicare Private Limited, Delhi Corona IgG antibody detection Test Indigenous 121. M/s Roche Ltd, Maharashtra Elecsys Anti-SARS-CoV-2 S (ECLIA) M/s Roche Diagnostics GmbH, Germany 122. M/s ADVY CHEMICAL PVT. LTD, Maharashtra Covid -19 IgG/IgM antibody test Uncut sheet M/s Humasis Co. Ltd., South Korea 123. M/s. BhartivaishHealthcare,
Jharkhand COVID-19 IgM/IgG Rapid Test ( INDICAID or ORAWELL) M/s. Jiangsu Well Biotech Co., Ltd, China 124. M/s Oscar Medicare Private Limited, Delhi Optra Shield-COVID-19 (IgG) Rapid Test Kit Indigenous 125. M/s Alere Medical Private Limited, Haryana
Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) M/s Abbott Diagnostics Korea Inc, South Korea 126. M/s EDGE PHARMA PRIVATE LIMITED, Mumbai EDGEXPRESS - COVID- 19 antibody detection test Indigenous 127. M/s Promea Therapeutics Private Limited, Hyderabad COVID 19 IgG ELISA Indigenous 128. M/s. ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, Goa Rapid test for detection of SARS-CoV-2 Antigen in human nasal swab (NS) and nasopharyngeal (NP) swab specimens
( PerkinElmer COVID-19 Antigen Test (NS, NP)) Indigenous 129. M/s Strumed Solutions Private Limited, Chennai iNSTAXPLOR COVID 19 RAPID ANTIGEN TEST Indigenous 130. M/s. Tricell Biologics Private Limited, Chennai COVID-19 Antigen Rapid Test Kit M/s Panion& BF Biotech Inc., Taiwan 131. M/s. Immunoscience Pune ImmunoQuickRapid Test for Detection of COVID-19 Antigen-Device & Indigenous

Page 9 of 17 132.
ImmunoQuickRapid Test for Detection of Novel Coronavirus (COVID-19) IgG AntibodiesDevice Indigenous 133. M/s Abbott Healthcare Pvt. Ltd, Chennai SARS-CoV-2 IgG II Quant Reagent Kit( (CMIA) (Used on ARCHITECT i System) M/s Abbott Ireland Diagnostics Division, Ireland. 134. M/s Zephyr Biomedicals A Division Of Tulip Diagnostics Private Limited, Goa. Anti-SARS Coronavirus COVID-19 IgG ELISA for the qualitative detection of IgG antibodies to SARS CoV-2 in human serum/plasma

( QUALISA COVID 19 IgG ELISA) Indigenous 135. M/s. Ortho Clinical Diagnostics India Private Limited, Thane, Maharashtra. VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack M/s Ortho Clinical Diagnostics Inc, USA 136. M/s Siemens Healthcare Private Limited, Haryana Dimension® EXL™ SARSCoV2 IgG (CV2G) Assay

M/s Siemens Healthcare Diagnostics Inc, USA 137. M/s Diagnocure India, Solan , HP Xamin Covid-19 IgG Rapid Test Device Indigenous 138. M/s Abbott Healthcare Pvt. Ltd, Chennai SARS-CoV-2 IgG II Quant Reagent Kit( (CMIA) (Used on Alinityi system.) M/s Abbott Ireland Diagnostics Division, Ireland. 139. M/s ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, Goa COVIRAT -Rapid test for detection of SARS-CoV-2 Antigen in human nasopharyngeal swab specimens (Device) Indigenous 140. M/s Advy Chemical Pvt Ltd, Mumbai EzDxCovid-19 Rapid Antigen test for the Qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab Specimen Indigenous 141. M/s Meril Diagnostics Private Limited, COVID-19 Neutralizing Antibody ELISA Test(Meriscreen) Indigenous 142. M/s. Ortho Clinical Diagnostics India Private Limited, Mumbai VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack M/s Ortho Clinical Diagnostics, UK 143. M/s Roche Ltd., Mumbai SARS-CoV-2 Rapid Antigen Test M/s SD Biosensor, South Korea

Page 10 of 17 144. M/s Sidak Life Care Pvt Ltd, New Delhi Antigen Test Kit (COVID 19) Indigenous 145. M/s Beckman Coulter Chennai ACCESS SARS-CoV-2 IgG II Reagent Kit (CLIA) M/s Beckman Coulter, Inc., USA 146. M/s Meril Diagnostics Private Limited, Gujarat Covid-19 Neutralizing Antibody Rapid Test(EVO) (Additional brand) Indigenous 147. M/s J. MITRA & CO. PVT. LTD COVID-19 Neutralizing Antibody Microlisa Indigenous 148. M/s Meril Diagnostics Private Limited, Gujarat COVID-19 Neutralizing Antibody ELISA Test (Merilisa) Indigenous 149. M/s Oscar Medicare Private Limited, Delhi Corona IgG Antibody Detection Test Indigenous 150. M/s Trivitron Healthcare Pvt. Ltd, Chennai SARS-CoV-2 S-RBD IgG (CLIA) M/s Shenzhen New Industries Biomedical Engineering Co., Ltd, China 151. M/s PREMIER MEDICAL CORPORATION
PRIVATE LIMITED, Gujarat COVID-19 Antigen Card Test (NC/PC) - Sure Status Indigenous 152.
COVID-19 Antigen Card Test (Home Test - Export) - Sure Status Indigenous 153. \ M/s Meril Diagnostics Private Limited, Gujarat COVID-19 IgG/IgM Rapid Test ( EVO) (Additional brand) Indigenous 154.
COVID-19 Antigen Detection Test( EVO) (Additional brand) Indigenous 155. M/s Meril Diagnostics Private Limited, Gujarat COVID-19 Antigen Detection Test (MERISCREEN PLUS) Indigenous 156. M/s Siemens Healthcare Private Limited, Gurgaon ADVIA Centaur SARS- CoV2 IgG (sCOVG) (CLIA) M/s Siemens Healthcare Diagnostics Inc, USA 157. M/s Biofootprints Healthcare Pvt Ltd, New Delhi Mytest COVID-19 Ag Test Kit Indigenous 158. M/s Diagnocure India, Baddi, Solan XAMIN COVID-19 Ag Rapid Test Device Indigenous 159. M/s Oscar Medicare Private Limited, Haridwar, Uttarakhand OSCAR Corona Antigen Test Indigenous

Page 11 of 17 (India) 160. M/s. Meril Diagnostics Private Limited, Gujarat Meril COVID-19 antigen detection test (FIA) Indigenous 161. M/s Vanguard Diagnostics Pvt. Ltd, New Delhi. DIPCOVAN&DIPAS-VDx Covid 19 IgG ELISA test kit Indigenous 162. M/s Medzome Life Sciencez Private Limited, New Delhi FutureCare COVID-19 Antigen Detection Kit Indigenous 163. M/s PATHSHODH HEALTHCARE PVT LTD, Bangalore anuPathCOVID-19 Total Antibody (IgM+IgG) Test Strips Indigenous 164. M/s Roche Ltd, Mumbai SARS-CoV-2 Rapid Antigen Test Nasal M/s SD Biosensor, South Korea. 165. M/s Roche Ltd, Mumbai Elecsys SARS-CoV-2 Antigen (ECLIA) M/s Roche Diagnostics GmbH, Germany 166. M/s Alere Medical Private Limited, Rewari, Haryana Panbio™ COVID-19 Ag Rapid Test Device (Nasal) M/s Abbott Diagnostics Korea Inc, South Korea 167. M/s M/s Athenese -Dx Private Limited, Chennai TRUSTlineCOVID-19 Ag Rapid Test Indigenous 168. M/s Becton Dickinson Chennai BD Veritor System For Rapid Detection of SARS- CoV-2 Antigen (chromatographic digital immunoassay) M/s BD Rapid Diagnostics (Suzhou) Co. Ltd., China 169. M/s Becton Dickinson Chennai BD Veritor System For Rapid Detection of SARS- CoV-2 (Model no. 256082) M/s BD Rapid Diagnostics (Suzhou) Co. Ltd, China 170. M/s. Peerless Biotech Pvt. Ltd. Chennai Flowflex SARS-CoV-2 Antigen Rapid Test M/s Acon Biotech (Hangzhou) Co. Ltd., China. 171. M/s Diasorin Healthcare India Pvt. Ltd, Mumbai LIAISON® SARS-CoV-2 IgM (CLIA) M/s DiaSorin S.p.A., Italy 172. M/s Trivitron Healthcare Pvt. Ltd, Chennai SARS-CoV-2 Neutralizing Antibody (CLIA) M/s Shenzhen New Industries Biomedical Engineering Co., Ltd, China 173. M/s QIAGEN India Pvt. Ltd, Delhi mo-screen Corona Antigen Test M/s Zhejiang Orient Gene Biotech Co., Ltd, China

Page 12 of 17 174. M/s SNIBE DIAGNOSTIC (India) Private Limited, Gurgaon MAGLUMI SARS-CoV-2 Ag (CLIA) M/s Shenzhen New Industries Biomedical Engineering Co., Ltd., China 175.
MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) 176.
MAGLUMI SARS-CoV-2 S- RBD IgG (CLIA) 177. M/s. Microlyn Healthcare Private Limited, Chennai SARS-COV-2 IgG M/s DIALAB Produktion, Austria
178. M/s Imperial Life Sciences Pvt. Ltd,
Gurgaon, Haryana BIOCREDIT COVID-19 Ag M/s RapiGEN INC., South Korea 179. M/s Becton Dickinson Chennai BD Kit for Rapid Detection of SARS-CoV-2 Antigen M/s BD Rapid Diagnostics (Suzhou) Co. Ltd., China 180. M/s Biolab Ltd, Mumbai Rapid diagnostics kit for Covid 19 Antigen Indigenous
181. M/s. Ortho Clinical Diagnostics India Private Limited, Mumbai VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 Reagent Pack M/s Ortho Clinical Diagnostics, UK 182. M/s Immunoshop India Pvt Ltd, Mumbai MAGLUMI - SARS-CoV-2 S-RBD IgG (CLIA) M/s Shenzhen New Industries Biomedical Engineering Co., Ltd, China 183.
MAGLUMI SARS-CoV-2 Neutralizing Antibody 184. M/s Matrix Labs, Chennai SARS-CoV-2 IgG II CLIA Microparticles M/s Autobio Diagnostics Co. Ltd, China 185.
SARS-CoV-2 IgM II CLIA Microparticles 186.
Anti-SARS-CoV-2 RBD CLIA Microparticles and
SARS-CoV-2 NAb Q CLIA Microparticles 187. M/s Weldon Biotech India Pvt. Ltd, Delhi Ichroma COVID-19 Ag M/s Boditech Med Inc., South Korea 188. M/s Nulife, Noida AbChek Covid-19 Antigen Rapid test kit Indigenous
189. M/s Agappe Diagnostics Ltd. Kerala AG-Q COVID-19 N Antigen Rapid Diagnostic Test Kit Indigenous
190. M/s Biotime Healthcare Pvt Ltd, Ahmedabad, Gujarat Vazyme Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV- 2) Antigen M/s Nanjing Vazyme Medical Technology Co., Ltd, China 191. M/s YUVRAJ BIOBIZ INCUBATOR INDIA PRIVATE LIMITED, Chennai YBIO COVID19 AG TEST Indigenous
192. M/s TCM Limited, Kerala fluorecare SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic M/s Shenzhen Microprofit Biotech Co. Ltd., China

Page 13 of 17 Immunoassay) 193. M/s MYLAB DISCOVERY SOLUTION PVT. LTD, Pune
COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST Indigenous
194. M/s Diagnostic Enterprises, HP COVID 19 ANTIGEN CARD Indigenous
195. M/s Dia Sure Immunodiagnostic LLP, Delhi DSI Rapid Antigen Test for Novel Corona Virus (nCOVID-19) Indigenous
196. M/s PerkinElmer Health Sciences Pvt. Ltd, Chennai GSP®/DELFIA® Anti- SARS-CoV-2 IgG kit M/s Wallac Oy, Finland 197. M/s. Ortho Clinical Diagnostics India Private Limited, Mumbai VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack M/s Ortho Clinical Diagnostics, UK 198. M/s Matrix Labs, Chennai Finecare™ 2019-nCoV Antigen Test M/s GUANGZHOU WONDFO BIOTECH CO. LTD, China 199. M/s J. MITRA & CO. PVT. LTD., New Delhi COVID 19 Ag Microlisa - ELISA Indigenous
200. M/s BIODX HEALTHCARE, New Delhi SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) M/s Zybio Inc, China 201. M/s INVEX HEALTH PRIVATE LIMITED, MP Wondfo 2019- nCoV Antigen Test M/s Guangzhou Wondfo Biotech Co, Ltd., China 202. M/s POCT Services Private Limited, New Delhi Flowflex Sars-COV-2 Antigen Rapid Test M/s Acon Biotech (Hangzhou) Co. Ltd. China 203. M/s DEEP MEDITECH PVT. LTD, New Delhi Flowflex Sars-COV-2 Antigen Rapid Test M/s Acon Biotech (Hangzhou) Co., Ltd., China 204. M/s Regulatory1, Bengaluru SARS-CoV-2 Antigen Test Kit (LFIA) M/s Jiangsu Medomics Medical Technology Co. Ltd, China 205. M/s Viola Diagnostic Systems - A Division Of Tulip Diagnostics Private Limited,, PANTNAGAR, Uttarakhand
Rapid test for detection of SARS-CoV-2 Antigen in human nasopharyngeal swab specimens (Device) Indigenous
206. M/s Vishat Diagnostic Pvt Ltd, Mumbai All Test COVID-19 Antigen Rapid Test M/s Hangzhou AllTest Biotech Co., Ltd., China 207. M/s PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Gujarat COVID-19 Antigen Card Test (Nasal Swab) FOR EXPORT ONLY Indigenous
208. M/s Meril Diagnostics Private Limited, Gujarat Covid-19 Antigen Self Test Indigenous
209. M/s Alere Medical Private Limited,
Panbio COVID-19 Antigen Self Test M/s Abbott Diagnostics Korea Inc, South Korea

Page 14 of 17 Haryana 210. M/s Excel Global Health, Karnataka V-Strip COVID-19 Rapid Antigen Test Kit M/s Panion & BF Biotech Inc., Taiwan 211. M/s PATHKITS HEALTHCARE PRIVATE LIMITED, Haryana PathKits SimpleCOVID-19 Ag Rapid Test Indigenous
212. M/s Cadila Healthcare Limited, Gujarat ZyCoRapSARS CoV-2 Antigen Rapid Test Indigenous
213. M/s Lab-Care Ltd., Gujarat COVID-19 Neutralizing Antibody ELISA Kit Indigenous
214. M/s Diasorin Healthcare India Pvt. Ltd, Mumbai LIAISON® SARS-CoV-2 TrimericS IgG M/S DIASORIN INC. USA 215. M/s. CPC Diagnostics Pvt, Ltd, Chennai iFlash-2019-nCoV NAb M/s. Shenzhen YHLO Biotech Co., Ltd , China 216. M/s Hotgen Biotech Mumbai Novel Coronavirus 2019- nCoV Antibody Test (Up- converting Phosphor Immunochromatographic Technology) M/s Beijing Hotgen Biotech Co., Ltd., China 217. M/s Mylab Discovery Solutions Pvt. Ltd., Additional optional Site for Packing, Pune. CoviSelf TM COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST Indigenous
218. M/s Diabetomics Medical Private Limited, Telangana CovAbScreenTM SARS- CoV-2 Ab Test Indigenous
219. M/s. Ortho Clinical Diagnostics India Private Limited, Mumbai VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack M/s Ortho Clinical Diagnostics, UK 220. M/s Athenese -Dx Private Limited, Chennai TRUSTwell COVID-19 IgG ELISA Kit Indigenous
221. M/s GENES 2ME PVT. LTD, Delhi RapiCov Rapid Antigen Test Kit for COVID-19 Indigenous
222. M/s Becton Dickinson Chennai BD Veritor System For Rapid Detection of SARS- CoV-2 (Model no. 256089) M/s BD Rapid Diagnostics (Suzhou) Co. Ltd, China 223. M/s Meril Diagnostics Private Limited,
Gujarat CoviFind Covid-19 Antigen Test Indigenous
224. M/s Parekh Integrated Services Pvt. Ltd, Rewari, Haryana QuickVue® SARS Antigen Test M/s QUIDEL CORPORATION, California, USA. 225. M/s Parekh Integrated Services Pvt. Ltd, Rewari, Haryana LumiraDx SARS-CoV-2 Ag Test Strip Kit M/s LumiraDx UK Ltd., UK 226. M/s Oscar Medicare Private Limited, Delhi identi SARS-CoV-2 Rapid Antigen Test Indigenous
227. M/s Seloi Healthcare INSTA COVID Antigen Indigenous

Page 15 of 17 Pvt Ltd, Mumbai Rapid Test 228. M/s SD Biosensor Healthcare Pvt. Ltd, Gurgaon, Haryana
ULTRA COVID-19 Ag One Step COVID-19 Antigen Test (Additional Brand) Indigenous
229. M/s Nulife, Uttar Pradesh (India) - 201301 Home Test -Covid-19 Antigen Rapid kit Indigenous
230. M/s Transasia Bio- Medicals Ltd, Mumbai EbraQik COVID-19 Antigen Test Card Indigenous
231. M/s PATANJALI PHARMA PRIVATE LIMITED, Mumbai Cov Ant One Step Covid- 19 Antigen Test Indigenous
232. M/s SD Biosensor Healthcare Pvt.Ltd, Haryana ULTRA Covi-Catch , ULTRA CoviCatch One Step COVID-19 Antigen Test (Self Test) Indigenous
233. M/s. NeoDx Biotech Labs Pvt Ltd, Bengaluru Cassette - SARS-CoV-2 Antigen Test M/s. ACON Biotech (Hangzhou) Co., Ltd., China 234. M/s Advy Chemical Pvt Ltd, Thane EzDx Covid -19 neutralizing antibody detection rapid test Indigenous
235. M/s Transasia Diagnostics Private Limited, Andhra Pradesh (India) - 530031 Erba Lisa® COVID-19 IgG

Indigenous
236. M/s.Poly Medicure Limited, Faridabad, Haryana (India). One step COVID-19 Antigen detection test device Indigenous
237. M/s KOSHBIO PRIVATE LIMITED, Delhi (India) - 110065 SARS-CoV-2: Rapid Antigen Test Indigenous
238. M/s LORVEN BIOLOGICS PRIVATE LIMITED, Hyderabad Lorven Antigen Rapid Detection Test Kit Indigenous
239. M/s Angstrom Biotech Pvt. Ltd., Alwar, Rajasthan. ANG CARD COVID - 19 Antigen - Saliva (Self Test Kit) Indigenous
240. M/s Voxtur Bio Ltd,
Maharashtra (India) Voxpress COVID-19 Neutralizing Antibody Test Indigenous
241. M/s Achira Labs Pvt. Ltd, Bengaluru COVISTAR SARS-CoV-2 IgG ELISA Kit Indigenous
242. M/s SD Biosensor Healthcare Pvt. Ltd, Haryana (India)
COVID-19 At-Home Test (Additional brand) Indigenous
243. M/s Siemens Healthcare Private Limited, Gurgaon. CLINITEST® Rapid COVID- 19 Antigen Self- Test M/s Healgen Scientific Limited Liability Company, USA @ : M/s Zhejiang Orient Gene Biotech Co.,Ltd, China

Page 16 of 17 244. M/s J. MITRA & CO. PVT. LTD., A - 180 / 181, Delhi (India) - 110020 COVID 19 Ag Card Indigenous
245. M/s Roche Diagnostics India Private Limited @
M/s SD Biosensor Healthcare Pvt. Ltd,
Gurgaon, Haryana COVID-19 At Home Test Indigenous
246. M/S Boditech Med Mumbai AFIAS COVID-19 Ag (FIA) M/s Boditech Med Inc, South korea 247. M/s Bhat Bio Tech India (P) Ltd, Bengaluru Bhat Bio-Scan :Covid19 IgG Antibody Elisa Test Indigenous 248. M/s Tata Medical And Diagnostics Limited at NuLife, UP TATA MD CHECK COVID- 19 Antigen Self-Test Kit Indigenous 249. M/s Mylab Discovery S0lutions Pvt. Ltd,
Pune PathoCatch™, Gazelle™ COVID-19 FIA Ag Test Kit
Indigenous 250. M/s. Zephyr Biomedicals A Division Of Tulip Diagnostics Private Limited, Goa COVIRAT Rapid test for detection of SARS-CoV-2 Antigen in Human Nasal Swab Specimen at Home (Device) Indigenous 251. M/s Genes2Me Private Limited, Haryana (India) CoviEasy COVID-19 Rapid Antigen Self Test Indigenous 252. M/s Premier Medical Corporation Private Limited, Gujarat. Sure Status® COVID-19 Antigen Card Test
(Home Test) Indigenous 253. M/s Kilpest India Limited, MP TRURAPID® COVID-19 Ag Test Indigenous 254. M/s Edge Pharma Private Limited, Mumbai EdgeXpress COVID-19 Antigen detection test Indigenous 255. M/s Nucleus Diagnosys LLP, Ahmedabad, Gujarat. Covid-19 Rapid Antigen Test Indigenous 256. M/s Viola Diagnostic Systems - A Division Of Tulip Diagnostics Private Limited,
Uttarakhand PerkinElmer Rapid Cassette Test for Detection of SARS-CoV-2 Antigen in Human Nasal Swab Specimen at Home (FOR EXPORT ONLY) Indigenous 257. M/s BIOSCI HEALTH CARE, MP BioSci True-Detect COVID- 19 Antigen Test Kit Indigenous 258. M/s Imgenex India Private Limited, Orissa ImCoV-Ag SARS-CoV-2 Rapid Antigen Test Kit Indigenous 259. M/s Recombigen Laboratories Private Limited, Delhi Covid 19 Antigen Test Kit Indigenous 260. M/s NeoDx Biotech NeoCheck Rapid Antigen Indigenous

Page 17 of 17

Labs Private Limited, Bangalore.
Self Testing Kit for COVID- 19 261. M/s PREMAS LIFE SCIENCES PVT. LTD, New Delhi cPass SARS-CoV-2 Neutralization Antibody Detection kit M/s Nanjing Genscript Diagnostics Technology Co., Ltd, China 262. M/s. South India Surgical Co Ltd, Chennai GLINE-2019-nCoV Ag Saliva Indigenous 263. M/S Anamol Laboratories Pvt. Ltd., Palghar, Maharashtra InstaCOVID Ag Covid-19 Rapid Antigen Test Kit Indigenous 264. M/s ImmunoScience India Private Limited, Pune TruCoV-Flow Ultrasensitive COVID-19 Saliva Based Rapid Antigen Test-Device & Components Indigenous 265. M/s Tata Medical And Diagnostics Limited at M/s. NuLife, Uttar Pradesh TATA MD CHECK Ag Pro COVID-19 Rapid Antigen card test Indigenous 266. M/s SD Biosensor Healthcare Pvt.Ltd, Haryana ULTRA COVID-19 Ag (Additional brand) Indigenous 267. M/s Krishgen Pudgala LLP, Thane, Maharashtra Anti-SARS-CoV-2 (Covid- 19) IgG Antibody to nucleoprotein Qualitative ELISA Indigenous 268. M/s Krishgen Pudgala LLP, Thane, Maharashtra Anti-SARS-CoV-2 (Covid- 19) IgG Antibody to spike protein RBD Qualitative ELISA Indigenous 269. M/s EDGELABS LLP, Mumbai EdgeXpress Covid 19 IgG IgM Antibodies detection test Indigenous 270. M/s EDGELABS LLP, Mumbai EdgeXpress Covid 19 Antigen detection test Indigenous 271. M/s Meril Diagnostics Private Limited, Gujarat Covid-19 Antigen Self Test (NanoRepro) Indigenous 272. M/s Vanguard Diagnostics Private Limited, Delhi (India) VDx SARS-CoV2 Neutralizing Antibody Test Kit Indigenous 273. M/s Reckon Diagnostics Pvt Ltd, Gujarat Test reagent / kit for COVID-19 AntigenRapid Test Indigenous 274. M/s. Nanz Med Science Pharma Private Limited,
Himachal Pradesh COVINO Covid-19 Antigen Test Indigenous 275. M/s Regulatory1, Bengalaru Hotgen Coronavirus (2019- nCoV)-Antigen Self-test M/s. M/s Beijing Hotgen Biotech Co., Ltd, China