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Flow Through Anti-HCV Spot / Immunodot Test Kit - India CDSCO Medical Device Registration

Flow Through Anti-HCV Spot / Immunodot Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_73717a8986a357f7d9401472fa1b9941_71ae0fcf5910c4d9e2b43b50e051d783. 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
Flow Through Anti-HCV Spot / Immunodot Test Kit
UID: MFG/IVD/2019/000025_73717a8986a357f7d9401472fa1b9941_71ae0fcf5910c4d9e2b43b50e051d783

Brand Name

Poly Specific

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Signalยฎ HCV Ver. 3.0 - Flow through Anti-HCV Spot / Immunodot Test Kit is simple, rapid and an in vitro qualitative screening test for detection of antibodies to Hepatitis C Virus (Poly Specific) using samples of human serum or plasma to diagnose HCV infection. The test does not require any additional instrument. The assay is intended for use by skilled Health Care Workers / Laboratory Professionals, for an initial screening only. Reactive samples should be confirmed by a confirmatory assay

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