Calibrator Kit - PSA TPSA Cal
Calibrator Kit - PSA TPSA Cal (25000002) is a Class II device made by Qualigen Inc., cleared under FDA 510(k) K003096 on 30 Nov 2000 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816467020020), 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 | Number00816467020020 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK003096 | Date30 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00816467020020
- FDA 510(k) database K003096
Across registries
- FDA 510(k) K003096 decided 30 Nov 2000 Active
- FDA GUDID UDI-DI 00816467020020 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K003096
- Listed FDA GUDID 00816467020020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Calibrator Kit - PSA
- Generic name
- Total prostate specific antigen (tPSA) IVD, calibrator
- Model / Ref / Catalog
- TPSA Cal, 25000002
- Primary DI / UDI-DI
- 00816467020020
- 510(k) Number
- FDA product code
- JIT
- GMDN term
- Total prostate specific antigen (tPSA) IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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