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OSOM COVID-19 Test 1092

by Sekisui Diagnostics, LLC

OSOM COVID-19 Test 1092 is a Class II device made by Sekisui Diagnostics, LLC, listed in FDA GUDID since 19 Jan 2026 (UDI-DI 00742860100673), 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 Number00742860100673 UDI-DI Date19 Jan 2026ListedStatusListed 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  • Withdrawn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
OSOM COVID-19 Test
Generic name
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
1092
Primary DI / UDI-DI
00742860100673
FDA product code
QVF
GMDN term
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
866.3982
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: OSOM®

Similar devices

Other devices filed under FDA product code QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings).

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)