Saudi Arabia SFDA registration ME0000001020SFDAA00349
Access® HCV Ab V3
Saudi Arabia·Chemicals·Bio-Rad·Annex II List AActiveProduct information
Qualitative detection of anti-HCV antibodies in human serum and plasma
Product use
The Access HCV Ab V3 is intended to be used as an aid in the diagnosis of HCV infection and as a screening test for blood and plasma donors. The assay is not intended for the testing or screening of pooled specimens.
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001020SFDAA00349
- Authorization ID
- MDMA-1-2019-2654
- Status
- Active
- Expire Date
- May 13, 2027
Manufacturer
- Manufacturer Name
- Bio-Rad
Model information
- Model ID(s)
- B33458
Product accessories
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About this record
Access comprehensive regulatory information for Access® HCV Ab V3 in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List A device is registered with Saudi Arabia SFDA under registration number ME0000001020SFDAA00349 and manufactured by Bio-Rad.
This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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