Precision DX PREDX-ADT-MTD
by American Screening, L.L.C. 2 variants
Precision DX PREDX-ADT-MTD is a Class II device made by American Screening, L.L.C., cleared under FDA 510(k) K180349 on 5 Apr 2018 and listed in FDA GUDID since 11 Nov 2022 (UDI-DI 00840050510643), active as of 23 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 | Number00840050510643 | Date11 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180349 | Date5 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 00840050510643
- FDA 510(k) database K180349
Across registries
- FDA 510(k) K180349 decided 5 Apr 2018 Active
- FDA GUDID UDI-DI 00840050510643 listed 11 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K180349
- Listed FDA GUDID 00840050510643
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Precision DX
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / reference
- PREDX-ADT-MTD
- Primary DI / UDI-DI
- 00840050510643
- FDA product code
- NFW, PTG, QBF, QAW, NFT, NFV, NGL, NFY, PTH, NGM, NGG
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3870, 862.3620, 862.3700, 862.3910, 862.3100, 862.3170, 862.3650, 862.3250, 862.3150, 862.3610
- GUDID distribution status
- In Commercial Distribution