CHIKUNGUNYA ANTIBODY TEST KIT - India CDSCO Medical Device Registration

CHIKUNGUNYA ANTIBODY TEST KIT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000077_a4d99c65f1fb0c60ea9361b4507e0aaf_78188e9fc17f376ffc17976b7993197e. 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 B. The approving authority is North West Delhi Division.

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CDSCO Registered

Class Class B

CHIKUNGUNYA ANTIBODY TEST KIT

UID: MFG/MD/2019/000077_a4d99c65f1fb0c60ea9361b4507e0aaf_78188e9fc17f376ffc17976b7993197e

Brand Name

RECOMBIGEN

License Holder

RECOMBIGEN LABORATORIES PVT. LTD

Device Class

Class B

Approving Authority

North West Delhi Division

Product Information

The ChikungunyaIgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya virus （CHIK） in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the ChikungunyaIgM Rapid Test must be confirmed with alternative testing method(RECOMBIGEN) and clinical findings

Class B

GLUCOSE-6-PHOSPHATE DEHYDROGENASE REAGENT TEST KIT

Brand: RECOMBIGEN

RECOMBIGEN LABORATORIES PVT. LTD

Class B

Brand: RECOMBIGEN

Class B