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Acucy Flu Test Kit 1010

by Sekisui Diagnostics, LLC

Acucy Flu Test Kit 1010 is a Class II device made by Sekisui Diagnostics, LLC, listed in FDA GUDID since 20 Aug 2019 (UDI-DI 00742860100376), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00742860100376 UDI-DI Date20 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Acucy Flu Test Kit
Generic name
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Model / reference
1010
Primary DI / UDI-DI
00742860100376
FDA product code
PSZ
GMDN term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
866.3328
GUDID distribution status
In Commercial Distribution

Related devices

Category: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under Influenza A/B virus antigen IVD, kit, rapid ICT, clinical.

Other devices from Sekisui Diagnostics, LLC

See all devices from Sekisui Diagnostics, LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)