iScreen™ ABTDOAW110401A

by Instant Technologies, Inc.

iScreen ABTDOAW110401A 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 9 Nov 2022 (UDI-DI 00817405023462), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817405023462 UDI-DI	Date9 Nov 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK202567	Date25 Sep 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817405023462
FDA 510(k) database 510(k) number K202567

Across registries

2 registries list this device

FDA 510(k) K202567 decided 25 Sep 2020 Active
FDA GUDID UDI-DI 00817405023462 listed 9 Nov 2022 Listed

Timeline

2 dated events

25 Sep 2020 Cleared FDA 510(k) K202567
9 Nov 2022 Listed FDA GUDID 00817405023462

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: iScreen™
Generic name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog: ABTDOAW110401A
Description: 10 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MTD300, OPI2000, OXY100, THC50

Primary DI / UDI-DI: 00817405023462
510(k) Number: K202567
FDA product code: NFT, PTH, NGL, NFV, NFY, NGG, PTG, NFW
GMDN term: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device class: Class II
Regulation number: 862.3100, 862.3150, 862.3650, 862.3170, 862.3250, 862.3610, 862.3620, 862.3870
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Prescription use
Over-the-counter
Convenience kit
Lot / batch number
Expiration date

Other properties (9, all answered No)