Immunochromatographic one step rapid visual test for HIV 1 & 2 antibody in Human Serum, Plasma or Whole Blood-Device - India CDSCO Medical Device Registration

Immunochromatographic one step rapid visual test for HIV 1 & 2 antibody in Human Serum, Plasma or Whole Blood-Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_97f514067e586cba186f777fdab77b59_dd25f0279cf0f85203d6b90ae97f7eb8. This device is marketed under the brand name Poly Specific. The license holder is ARKRAY HEALTHCARE PVT. LTD., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Immunochromatographic one step rapid visual test for HIV 1 & 2 antibody in Human Serum, Plasma or Whole Blood-Device

UID: MFG/IVD/2019/000025_97f514067e586cba186f777fdab77b59_dd25f0279cf0f85203d6b90ae97f7eb8

Brand Name

Poly Specific

License Holder

ARKRAY HEALTHCARE PVT. LTD.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Crystal HIV-1/2 is an in vitro rapid qualitative screening test for diagnosis of HIV-1 (Poly Specific) and HIV-2 infection using human serum, plasma or whole blood