Dengue NS1 Antigen - India CDSCO Medical Device Registration

Dengue NS1 Antigen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000075_68c4a663c0899a0777bf84bee781a55c_e466fdd5b43ee62690c3f4bfe1edb5ad. This device is marketed under the brand name RECOMBIGEN. The license holder is RECOMBIGEN LABORATORIES PVT. LTD, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered

Class Class C

Dengue NS1 Antigen

UID: MFG/MD/2020/000075_68c4a663c0899a0777bf84bee781a55c_e466fdd5b43ee62690c3f4bfe1edb5ad

Brand Name

RECOMBIGEN

License Holder

RECOMBIGEN LABORATORIES PVT. LTD

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The proposed IVD product is a “Rapid Dengue NS1 antigen detection Kit in plastic cassette format”. It is intended for qualitative detection of Dengue NS1 antigen in human serum, plasma and whole blood sample

DJ Fang

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INFLUENZA-A ANTIGEN

Brand: RECOMBIGEN

RECOMBIGEN LABORATORIES PVT. LTD

Class C

INFLUENZA-B ANTIGEN

Brand: RECOMBIGEN

RECOMBIGEN LABORATORIES PVT. LTD

Class C

LYSE REAGENT KIT

Brand: RECOMBIGEN

RECOMBIGEN LABORATORIES PVT. LTD

Dengue NS1 Antigen - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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INFLUENZA-A ANTIGEN

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RINSE REAGENT KIT

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BLOOD CELL DILUENT KIT

CHIKUNGUNYA ANTIBODY TEST KIT

RAPID PLASMA REAGIN TEST KIT

Calcium Reagent Test Kit

GLUCOSE-6-PHOSPHATE DEHYDROGENASE REAGENT TEST KIT