Hepatitis C Check 27
by Home Access Health Corporation
Hepatitis C Check 27 is a capillary blood collection set (FDA Class II; FDA product code MZO, Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus) made by Home Access Health Corporation, approved under FDA PMA P980046 on 28 Apr 1999 and listed in FDA GUDID since 3 Sep 2015 (UDI-DI M769HCV271), active as of 8 Nov 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM769HCV271 | Date3 Sep 2015 | StatusListed |
| United States | FDA PMAAPPR | NumberP980046 | Date28 Apr 1999 | StatusActive |
Official records
- FDA PMA database P980046
Across registries
- FDA PMA P980046 decided 28 Apr 1999 Active
- FDA GUDID UDI-DI M769HCV271 listed 3 Sep 2015 Listed
Recalls
-
- Terminated Z-0150-2007
Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.
Timeline
- Approved FDA PMA P980046
- Recall initiated FDA recalls Z-0150-2007
- Listed FDA GUDID M769HCV271
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Hepatitis C Check
- Generic name
- Capillary blood collection set, home-use
- Model / reference
- 27
- Primary DI / UDI-DI
- M769HCV271
- PMA number
- FDA product code
- MZO
- GMDN term
- Capillary blood collection set, home-use
- Device class
- Class II
- Regulation number
- 866.3169
- GUDID distribution status
- In Commercial Distribution
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