RF Rapid Test - India CDSCO Medical Device Registration

RF Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_f07c943877164fe9ac989435c811f635_5d797df24a01f7d64b138142e37d1eb9. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

RF Rapid Test

UID: IMP/IVD/2019/000307_f07c943877164fe9ac989435c811f635_5d797df24a01f7d64b138142e37d1eb9

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The RF Rapid Test is a lateral flow immunoassay for the qualitative detection of all subtypes of rheumatoid factor (RecombiLISA) in human serum, plasma or whole blood at a sensitivity of 8 IU/mL. It is intended to be used as a screening test and provides a preliminary test result to aid in the diagnosis of rheumatoid arthritis and Sjögren's syndrome

Class B

Leishmania Ab Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D