134 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23 2023-Dec-06 654 KB

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Dated: 29.11.2023

CDSCO updated list of Laboratories for conducting Performance Evaluation of
In - Vitro Diagnostic Medical Device

Sr. No . Category of In vitro Diagnostics Medical Devices Name of Testing facility 1. In-Vitro Diagnostic Reagents/ Kits for detection for HIV

1. National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309
2. ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India
3. ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India
4. Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004
5. Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi- 70
6. ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012
7. ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata Kolkata-700010

Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 9)National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029
10) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda,
Punjab-151001 11) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 12) National Centre for Disease Control CSU, Integrated disease surveillance programme, Civil Lines, Delhi, 110054 13) Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 2. In-Vitro Diagnostic Reagents/ Kits for detection for HBV

1. National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309
2. ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India
3. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
4. Christian Medical College & Hospital, Ida

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Scudder Road, Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi- 70 6) ICMR- National Institute of Immunohaematology, 13th floor, New Multistoreyed Building, KEM Hospital Campus, 7) ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010 8) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor 9) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 10) All India Institute of Medical Sciences, Pradesh 229405 11)National Institute of Mental Health and 12) Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 13) All India Institute of Medical Sciences, Bhubaneswar, Sijua, Post.

Dumuduma, Bhubaneswar- 751019. Nodal officer- Prof. (Dr.) Baijayantimala Mishra, e-mail- microbaijayantimala@aiimsbhubaneswar.edu.in 3. In-Vitro Diagnostic Reagents/ Kits for detection for HCV

1. National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309
2. ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India
3. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
4. Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004
5. Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi- 70
6. ICMR- National Institute of Eipidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
7. ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010
8. All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001

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9. All India Institute of Medical Sciences, Pradesh 229405
10. Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor 11)National Institute of Mental Health and
11. Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu

In vitro Diagnostic Reagents/ Kits for Blood Grouping or Tissue Typing

1. National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309
2. Indian Red Cross Society, 1, Red Cross Road, New Delhi
3. ICMR- National Institute of Pathology, Sadarjang Hospital Campus, Ansari Nagar West, New Delhi, Delhi 110029
4. ICMR- National Institute of Immunohaematology, 13th floor, New Multistoreyed Building, KEM Hospital Campus,
5. ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA
6. Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor
7. All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001
8. All India Institute of Medical Sciences, Pradesh 229405
9. National Institute of Mental Health and
10. Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu

In vitro Diagnostic Reagents/ Kits for detection of Cancer

1. ICMR- Institute of Cytology and Preventive Oncology (ICPO), I-7, Sector - 39, Noida 201301 Uttar Pradesh, INDIA
2. ICMR- National Institute of Pathology, ICMR- National Institute of Pathology, Sadarjang Hospital Campus, Ansari Nagar West, New Delhi, Delhi 110029
3. ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA
4. Medical College and Hospital (Department of Oncology/ Medical Oncology), 88, College St,

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Calcutta Medical College, College Square, Kolkata, West Bengal 700073 5) Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India 6) All India Institute of Medical Sciences, Bathinda, Punjab-151001 7) Tata Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata- 700156 8) Rajiv Gandhi Centre for Biotechnology 9) All India Institute of Medical Sciences, Pradesh 229405 6. In vitro Diagnostic Reagents/ Kits for Detection of Tuberculosis (TB)

1. ICMR- National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, Chetpet, Chennai – 600 031, India

2. ICMR- National Jalma Institute of Leprosy and other mycobacterial diseases P.O BOX 101, Dr. M. Miyazaki Marg, Tajganj, Agra – 282001

3. ICMR-Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha 751023

4. National Institute of Tuberculosis & Respiratory Diseases, Sri Aurobindo Marg, Near Qutub Minar New Delhi- 110030

5. National Tuberculosis Institute, 8, Bellary Road, Bangalore 560 003, India,

6. Rajan Babu T.B. Hospital, Kingsway Camp, GTB Nagar, Delhi 110009

7. Shantabai Devarao Shivaram Tuberculosis Research Centre & Rajiv Gandhi Institute of Chest Diseases, Someshwara Nagar 1st Main Road, Dharmaram College Post, Bangalore - 560 029

8. Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012

9. National Reference Laboratory for Tuberculosis, Department of Microbiology, Bhopal Memorial Hospital & Research Centre, under ICMR, DHR, Raisen Bypass Road, Near Karond Chouraha, Bhopal - 462038

10. Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor

11. All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001

12. All India Institute of Medical Sciences, Pradesh 229405

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13)National Institute of Mental Health and Milk Dairy, Bengaluru, Karnataka – 560029 14) All India Institute of Medical Sciences, Bhubaneswar, Sijua, Post.

Dumuduma, Bhubaneswar- 751019. Nodal officer- Prof. (Dr.) Baijayantimala Mishra, e-mail- microbaijayantimala@aiimsbhubaneswar.edu.in 7. In vitro Diagnostic Reagents/ Kits for Detection of Malaria

1. ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India)
2. ICMR- National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003.
3. ICMR- Vector Control Research Centre, Medical Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006
4. All India Institute of Medical Sciences, Division of Clinical Microbiology & Molecular Medicine, New Delhi-110029
5. All India Institute of Medical Sciences, Bathinda, Punjab-151001
6. Rajiv Gandhi Centre for Biotechnology
7. All India Institute of Medical Sciences, Pradesh 229405

In vitro Diagnostic Reagents/ Kits for Detection of Dengue

1. ICMR- Vector Control Research Centre, Medical Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006
2. ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India)
3. National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309
4. National Institute of Cholera and Enteric Diseases, P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010
5. Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004
6. King Institute, Guindy Flyover, Guindy Institutional Area, SIDCO Industrial Estate, Guindy, Chennai, Tamil Nadu 600032
7. Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi- 70
8. Rajiv Gandhi Centre for Biotechnology
9. All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001
10. All India Institute of Medical Sciences,

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Pradesh 229405 11) National Institute of Mental Health and Milk Dairy, Bengaluru, Karnataka – 560029 12) All India Institute of Medical Sciences, Bhubaneswar, Sijua, Post.

Dumuduma, Bhubaneswar- 751019. Nodal officer- Prof. (Dr.) Baijayantimala Mishra, e-mail- microbaijayantimala@aiimsbhubaneswar.edu.in 9. In vitro Diagnostic Reagents/ Kits for Detection of Chikungunya

1. ICMR-National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003.
2. ICMR- National Institute of Cholera and Enteric Diseases,P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010
3. ICMR- Vector Control Research Centre, Medical Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006
4. ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India)
5. Rajiv Gandhi Centre for Biotechnology
6. All India Institute of Medical Sciences, Bathinda, Punjab-151001
7. All India Institute of Medical Sciences, Pradesh 229405
8. National Institute of Mental Health and 10 In vitro Diagnostic Reagents/ Kits for Detection of Treponema pallidum (Syphilis)
9. National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309
10. ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India (Including HIV, HBV, HCV & Syphilis in single kit)
11. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India (Including HIV, HBV, HCV & Syphilis in single kit)
12. ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street,
13. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
14. Rajiv Gandhi Centre for Biotechnology

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7. All India Institute of Medical Sciences, Bathinda, Punjab-151001
8. All India Institute of Medical Sciences, Pradesh 229405
9. National Institute of Mental Health and
10. Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 11 In vitro Diagnostic Reagents/ Kits for Detection of Typhoid
11. ICMR-National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003.
12. ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010
13. Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012
14. Rajiv Gandhi Centre for biotechnology
15. All India Institute of Medical Sciences, Bathinda, Punjab-151001
16. All India Institute of Medical Sciences, Pradesh 229405
17. National Institute of Mental Health and 12 In vitro Diagnostic Reagents/ Kits for Detection of Influenza
18. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
19. ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA
20. Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010
21. Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj, New Delhi-70
22. Sawai Man Singh Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
23. Rajiv Gandhi Centre for Biotechnology
24. All India Institute of Medical Sciences, Bathinda, Punjab-151001

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7. All India Institute of Medical Sciences, Pradesh 229405 13 In vitro Diagnostic Reagents/ Kits for Detection of Toxoplasma Gondii
8. Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata , Kolkata- 700010
9. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
10. Rajiv Gandhi Centre for Biotechnology
11. All India Institute of Medical Sciences, Bathinda, Punjab-151001
12. All India Institute of Medical Sciences, Pradesh 229405
13. National Institute of Mental Health and 14 In vitro Diagnostic Reagents/ Kits for Detection of Rubella Virus & Cytomegalovirus
14. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
15. ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street,
16. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
17. Rajiv Gandhi Centre for Biotechnology
18. All India Institute of Medical Sciences, Bathinda, Punjab-151001
19. All India Institute of Medical Sciences, Pradesh 229405 15 In vitro Diagnostic Reagents/ Kits for Detection of Pneumonia
20. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
21. ICMR-National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, Chetpet, Chennai – 600 031, India
22. Rajiv Gandhi Centre for Biotechnology

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4. All India Institute of Medical Sciences, Bathinda, Punjab-151001
5. All India Institute of Medical Sciences, Pradesh 229405 16 In vitro Diagnostic Reagents/ Kits for Detection of Methicilline-Resistant Staphylococcus Aureus
6. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
7. ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010
8. Dept. of microbiology, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha 751019
9. Rajiv Gandhi Centre for Biotechnology
10. All India Institute of Medical Sciences, Bathinda, Punjab-151001
11. All India Institute of Medical Sciences, Pradesh 229405
12. National Institute of Mental Health and 17 In vitro Diagnostic Regents/Kits for detection of Entero Virus (A/B)
13. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
14. ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010
15. Rajiv Gandhi Centre for Biotechnology
16. All India Institute of Medical Sciences, Bathinda, Punjab-151001
17. All India Institute of Medical Sciences, Pradesh 229405 18 In vitro Diagnostic Reagents/ Kits for Detection of markers for Congenital disorders
18. ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street,
19. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
20. Division of Genetics, Dept. of Paediatrics’, All India Institute of Medical Sciences, New Delhi
21. Division of Genetics, Dept. of Paediatrics’,

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Maulana Azad Medical College, New Delhi 5) Any Central Government or State Government Laboratory of any hospital or of any institute. 6) Rajiv Gandhi Centre for Biotechnology 7) All India Institute of Medical Sciences, Patna Phulwarisharif, Patna, Bihar- 801507, India 8) All India Institute of Medical Sciences, Bathinda, Punjab-151001 9) All India Institute of Medical Sciences, Pradesh 229405 19 In vitro Diagnostic Reagents/ Kits for Detection of Neisseria Gonorrhoeae

1. ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street,
2. ICMR-Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha 751023
3. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
4. Rajiv Gandhi Centre for Biotechnology
5. All India Institute of Medical Sciences, Bathinda, Punjab-151001
6. All India Institute of Medical Sciences, Pradesh 229405 20 In vitro Diagnostic Reagents/ Kits for Detection and typing of Human Papilloma Virus infection
7. ICMR- National Institute of Virology, 20/ A, Dr. 411001, India
8. ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street,
9. ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077
10. Rajiv Gandhi Centre for Biotechnology
11. All India Institute of Medical Sciences, Bathinda, Punjab-151001
12. All India Institute of Medical Sciences, Pradesh 229405 21 In vitro
13. ICMR-National Institute of

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Diagnostic Reagents/ Kits for detection of Sickle Cell Immunohaematology (NIIH), Mumbai, 13Th Floor, New Multistoreyed Bldg, Kem Hospital Campus, Parel, Mumbai, Maharashtra 400012, Nodal officer- Dr. Prabhakar Kedar, e-mail- kedar.pr@icmr.gov.in 2) ICMR – National Institute of Research in Tribal Health (NIRTH), Jabalpur, Nagpur Road, Near Nscb Medical Collage, Dhanvantri Nagar, Shastri Nagar, Jabalpur, Madhya Pradesh 482003. Nodal officer- Dr. S. Rajasubramaniam, e-mail- rajasubramaniam.s@icmr.gov.in 3) ICMR – Regional Medical Research Centre (RMRC, Bhubaneswar, Regional Medical Research Center, Bhubaneswar, Odisha 751023. Nodal officer- Dr.Madhusmita Bal, e-mail- balmadhusmita@gmail.com 4) Regional Medical Research Centre (RMRC, Dibrugarh), N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA 5) ICMR– National Institute for Implementation Research on Non Communicable Diseases (NIIRNCD), Jodhpur, Icmr-Niirncd (Desert Medicine Research Centre), Jodhpur, New Pali Road, Jodhpur, Rajasthan 342005 Nodal officer- Dr. S. S. Mohanty, e-mail- Mohanty.s@dmrcjodhpur.nic.in 22 In vitro Diagnostic Reagents/ Kits for Detection of autoimmune Disorders Any Central Government or State Government Laboratory of any hospital or of any institute. 23 In vitro Diagnostic Reagents/ Kits for human Genetic testing Any Central Government or State Government Laboratory of any hospital or of any institute.

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