Flow Through Anti-HCV Spot / Immunodot Test Kit
- UID
- MFG/IVD/2019/000025_73717a8986a357f7d9401472fa1b9941_71ae0fcf5910c4d9e2b43b50e051d783
- Device class
- Class D
- Brand name
- Poly Specific
- License holder
- ARKRAY HEALTHCARE PVT. LTD.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Signal® 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
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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