Typhoid IgG/IgM Rapid Test - India CDSCO Medical Device Registration

Typhoid IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_5cfd1dfb634249e0dacd60c3617152e0_a3f21a0f4c0d6aa6171c0dce2862fd44. 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

Typhoid IgG/IgM Rapid Test

UID: IMP/IVD/2019/000307_5cfd1dfb634249e0dacd60c3617152e0_a3f21a0f4c0d6aa6171c0dce2862fd44

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of anti-Salmonella typhi (RecombiLISA) and paratyphi IgG and IgM in human serum or plasma. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with S. typhi and paratyphi

Class B

H. pylori Ab Combo Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D