Control Kit - PSA PSA Controls
Control Kit - PSA PSA Controls (25000003) is a Class I device made by Qualigen Inc., cleared under FDA 510(k) K003095 on 29 Nov 2000 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816467020167), 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 | Number00816467020167 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK003095 | Date29 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00816467020167
- FDA 510(k) database K003095
Across registries
- FDA 510(k) K003095 decided 29 Nov 2000 Active
- FDA GUDID UDI-DI 00816467020167 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K003095
- Listed FDA GUDID 00816467020167
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Control Kit - PSA
- Generic name
- Total prostate specific antigen (tPSA) IVD, control
- Model / Ref / Catalog
- PSA Controls, 25000003
- Description
- Two levels of controls for the following assays: TPSA, FPSA FPSA is not available in the US.
- Primary DI / UDI-DI
- 00816467020167
- 510(k) Number
- FDA product code
- JJX
- GMDN term
- Total prostate specific antigen (tPSA) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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