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N/A A003

by Zhengzhou Shiyi Biotech Co., Ltd.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16977977230031 UDI-DI Date28 Jan 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Model / Reference
A003
Primary DI / UDI-DI
16977977230031
FDA Product Code
GNX
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Device Class
Class I
Regulation Number
866.3330
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

Other devices from Zhengzhou Shiyi Biotech Co., Ltd.

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No