187 List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software 2022-May-05 103 KB

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Dated: 05 May 2022 List of Laboratories for conducting Performance Evaluation of
In-Vitro Diagnostics Medical Device (Analyzer, Instrument and software)
Sr. No. Category of In vitro Diagnostics Analyzer, Instrument
and software Particular of technology Name and address of Testing laboratory 1.
and software for detection of HIV RDT (Rapid Diagnostic Tests) ICMR-National AIDS Research Institute, Plot No. 73, G-Block, MIDC, Bhosari, Pune-26, Maharashtra
ICMR-National Institute of Cholera and Enteric Diseases, P-33, C.I.T Road, Scheme-XM, Beliaghata. Kolkata- 700010
EIA (Enzyme Immunoassays)/ CLIA (chemiluminescence immunoassays)/ ECLIA (electro chemiluminescence immunoassays) 700010
Western Blot/ Viral Lysate 700010
Molecular Diagnostic technologies (PCR, RT- PCR, etc.) 700010
2.
and software for detection of HBV RDT
ICMR-National AIDS Research Institute, Plot No. 73, G-Block, MIDC, Bhosari, Pune-26, Maharashtra Scheme-XM, Beliaghata. Kolkata- 700010
EIA / CLIA/ ECLIA Scheme-XM, Beliaghata. Kolkata- 700010
3.
and software for detection of HCV RDT
ICMR-National AIDS Research Institute, Plot No. 73, G-Block, MIDC, Bhosari, Pune-26, Maharashtra
Scheme-XM, Beliaghata. Kolkata- 700010
EIA / CLIA/ ECLIA Scheme-XM, Beliaghata. Kolkata- 700010

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Sr. No. Category of In vitro Diagnostics and software Particular of technology Name and address of Testing laboratory 4.
and software for detection of Tuberculosis (TB)

Molecular Diagnostic technologies (PCR, RT- PCR, etc.) National Reference Laboratory for Tuberculosis, department of Microbiology, Bhopal Memorial Hospital & Research Centre, under ICMR, DHR, Raisen Bypass Road, Near Karond Chouraha, Bhopal - 462038 Culture Based National Reference Laboratory for Tuberculosis, department of Microbiology, Bhopal Memorial Hospital & Research Centre, under ICMR, DHR, Raisen Bypass Road, Near Karond Chouraha, Bhopal - 462038 ZN Microscopy, FM Microscopy

National Reference Laboratory for Tuberculosis, department of Microbiology, Bhopal Memorial Hospital & Research Centre, under ICMR, DHR, Raisen Bypass Road, Near Karond Chouraha, Bhopal - 462038 5.
and software for detection of Dengue

RDT
700010
EIA / CLIA/ ECLIA 700010
6.
and software for detection of Chikungunya,

RDT
700010
EIA / CLIA/ ECLIA 700010
7.
and software for detection of Treponema pallidum (Syphilis)
RDT
ICMR-National AIDS Research Institute, Plot No. 73, G-Block, MIDC, Bhosari, Pune-26, Maharashtra
8.
and software for detection of Typhoid, Widal agglutination assay test 700010 Culture based testing 700010

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Sr. No. Category of In vitro Diagnostics and software Particular of technology Name and address of Testing laboratory 9.
and software for detection of Influenza Molecular Diagnostic technologies (PCR, RT- PCR, etc.) ICMR-National Institute Of Virology, Pune, 20-A, Dr. Ambedkar Road, Pune-411001 10.
and software for detection of Methicilline-Resistant Staphylococcus Aureus,
Culture based testing Scheme-XM, Beliaghata. Kolkata- 700010.