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Fastep COV-S35002H4

by Azure Biotech, Inc.

Fastep COV-S35002H4 is a device classified as Not classified made by Azure Biotech, Inc., listed in FDA GUDID since 22 Sep 2023 (UDI-DI 00810022630433), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810022630433 UDI-DI Date22 Sep 2023ListedStatusListed 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  • Withdrawn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
Fastep
Generic name
SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Model / reference
COV-S35002H4
Primary DI / UDI-DI
00810022630433
FDA product code
QKP
GMDN term
SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Device class
N
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Other devices from Azure Biotech, Inc.

See all devices from Azure Biotech, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)