Aptima® KIT, CONTROLS, HBV, VL, US IVD
by Hologic
Aptima® KIT, CONTROLS, HBV, VL, US IVD (PRD-03869) is a Class II device made by Hologic, approved under FDA PMA P170025 on 23 Jan 2018 and listed in FDA GUDID since 30 Jan 2018 (UDI-DI 15420045506763), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15420045506763 | Date30 Jan 2018 | StatusListed |
| United States | FDA PMAAPRL | NumberP170025 | Date23 Jan 2018 | StatusActive |
Official records
- AccessGUDID record 15420045506763
- FDA PMA database P170025
Across registries
- FDA PMA P170025 decided 23 Jan 2018 Active
- FDA GUDID UDI-DI 15420045506763 listed 30 Jan 2018 Listed
Timeline
- Approved FDA PMA P170025
- Listed FDA GUDID 15420045506763
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Aptima®
- Generic name
- Hepatitis B virus nucleic acid IVD, control
- Model / Ref / Catalog
- KIT, CONTROLS, HBV, VL, US IVD, PRD-03869
- Primary DI / UDI-DI
- 15420045506763
- PMA number
- FDA product code
- MKT
- GMDN term
- Hepatitis B virus nucleic acid IVD, control
- Device class
- Class II
- Regulation number
- 866.3174
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MKT (Hepatitis Viral B Dna Detection).