Poly stat STS25
Poly stat STS25 is a Class I device made by Polymedco, Inc., cleared under FDA 510(k) K040708 on 22 Nov 2004 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00855574005421), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00855574005421 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040708 | Date22 Nov 2004 | StatusActive |
Official records
- AccessGUDID record 00855574005421
- FDA 510(k) database K040708
Across registries
- FDA 510(k) K040708 decided 22 Nov 2004 Active
- FDA GUDID UDI-DI 00855574005421 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K040708
- Listed FDA GUDID 00855574005421
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Poly stat
- Generic name
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
- Model / reference
- STS25
- Primary DI / UDI-DI
- 00855574005421
- 510(k) Number
- FDA product code
- GTY
- GMDN term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3740
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.