iScreen™ ABTDOAW105401A
iScreen ABTDOAW105401A is a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., cleared under FDA 510(k) K202567 on 25 Sep 2020 and listed in FDA GUDID since 25 May 2023 (UDI-DI 00817405024001), 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 | Number00817405024001 | Date25 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202567 | Date25 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 00817405024001
- FDA 510(k) database K202567
Across registries
- FDA 510(k) K202567 decided 25 Sep 2020 Active
- FDA GUDID UDI-DI 00817405024001 listed 25 May 2023 Listed
Timeline
- Cleared FDA 510(k) K202567
- Listed FDA GUDID 00817405024001
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- Withdrawn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
- ABTDOAW105401A
- Description
- 5 panel CLIA Waived Urine Dip Card AMP1000, COC300,OPI2000,PCP25,THC50
- Primary DI / UDI-DI
- 00817405024001
- 510(k) Number
- FDA product code
- NFT, NFY, NGL, LCM, NFW
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3100, 862.3250, 862.3650, 862.3870
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.