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Immunochromatographic one step rapid visual test for Hepatitis-B surface antigen - Device - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
Immunochromatographic one step rapid visual test for Hepatitis-B surface antigen - Device
UID: MFG/IVD/2019/000025_6cb54b4fbc38abbf128aed24e0f83b93_f1bdfe2f719d4e11470b594d62b43cd4

Brand Name

Poly Specific

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Crystalยฎ 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

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Similar Products (10)
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