iScreen™ ABTDBUW11401A
iScreen ABTDBUW11401A is a multiple drugs of abuse IVD (FDA Class II; FDA product code NGL, Test, Opiates, Over The Counter) made by Instant Technologies, Inc., cleared under FDA 510(k) K202567 on 25 Sep 2020 and listed in FDA GUDID since 10 Feb 2023 (UDI-DI 00817405023592), 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 | Number00817405023592 | Date10 Feb 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202567 | Date25 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 00817405023592
- FDA 510(k) database K202567
Across registries
- FDA 510(k) K202567 decided 25 Sep 2020 Active
- FDA GUDID UDI-DI 00817405023592 listed 10 Feb 2023 Listed
Timeline
- Cleared FDA 510(k) K202567
- Listed FDA GUDID 00817405023592
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iScreen™
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- ABTDBUW11401A
- Description
- BUP CLIA WAIVED DIP CARD BUP10
- Primary DI / UDI-DI
- 00817405023592
- 510(k) Number
- FDA product code
- NGL
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3650
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.