ThinPrep 5000 Processor TP-5000 Autoloader Accessory Kit
by Hologic
ThinPrep 5000 Processor TP-5000 Autoloader Accessory Kit (ASY-08988) is a Class III device made by Hologic, approved under FDA PMA P950039 on 20 May 1996 and listed in FDA GUDID since 25 Sep 2020 (UDI-DI 15420045513952), 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 | Number15420045513952 | Date25 Sep 2020 | StatusListed |
| United States | FDA PMAAPPR | NumberP950039 | Date20 May 1996 | StatusActive |
Official records
- AccessGUDID record 15420045513952
- FDA PMA database P950039
Across registries
- FDA PMA P950039 decided 20 May 1996 Active
- FDA GUDID UDI-DI 15420045513952 listed 25 Sep 2020 Listed
Timeline
- Approved FDA PMA P950039
- Listed FDA GUDID 15420045513952
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- ThinPrep 5000 Processor
- Generic name
- Microscope slide maker IVD
- Model / Ref / Catalog
- TP-5000 Autoloader Accessory Kit, ASY-08988
- Primary DI / UDI-DI
- 15420045513952
- PMA number
- FDA product code
- MKQ
- GMDN term
- Microscope slide maker IVD
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MKQ (Processor, cervical cytology slide, automated).