Aptima® KIT, CONTROLS, HCV QUANT, US IVD
by Hologic
Aptima® KIT, CONTROLS, HCV QUANT, US IVD (PRD-03706) is a Class II device made by Hologic, cleared under FDA 510(k) K233352 on 24 Jul 2024 and listed in FDA GUDID since 8 Mar 2017 (UDI-DI 15420045506794), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) | NumberK233352 | Date24 Jul 2024 | StatusActive |
| United States | GUDID listing | Number15420045506794 | Date8 Mar 2017 | StatusListed |
Official records
- AccessGUDID record 15420045506794
- FDA 510(k) database K233352
Across registries
- FDA 510(k) K233352 decided 24 Jul 2024 Active
- FDA GUDID UDI-DI 15420045506794 listed 8 Mar 2017 Listed
Timeline
- Listed FDA GUDID 15420045506794
- Cleared FDA 510(k) K233352
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aptima®
- Generic name
- Hepatitis C virus nucleic acid IVD, control
- Model / Ref / Catalog
- KIT, CONTROLS, HCV QUANT, US IVD, PRD-03706
- Primary DI / UDI-DI
- 15420045506794
- 510(k) Number
- FDA product code
- MZP
- GMDN term
- Hepatitis C virus nucleic acid IVD, control
- Device class
- Class II
- Regulation number
- 866.3170
- GUDID distribution status
- In Commercial Distribution
Similar devices
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