Immunochromatographic one step rapid visual test for Hepatitis-B surface antigen - Device
- UID
- MFG/IVD/2019/000025_6cb54b4fbc38abbf128aed24e0f83b93_f1bdfe2f719d4e11470b594d62b43cd4
- Device class
- Class D
- Brand name
- Poly Specific
- License holder
- ARKRAY HEALTHCARE PVT. LTD.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Crystal® HBsAg - Immunochromatographic one step rapid visual test for Hepatitis-B surface antigen - Device is an in vitro qualitative screening test to diagnose Hepatitis-B using human serum or plasma. It is intended for screening of blood donors and individuals suspected of Hepatitis B virus infection
Immunochromatographic one step rapid visual test for Hepatitis-B surface antigen - Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_6cb54b4fbc38abbf128aed24e0f83b93_f1bdfe2f719d4e11470b594d62b43cd4. 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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