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Biomeme SARS-CoV-2 Go-Strips Kit 1

by Biomeme, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810096640048 UDI-DIDate2 Dec 2022ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Biomeme SARS-CoV-2 Go-Strips Kit
Generic Name
Nucleic acid amplification mastermix kit IVD
Model / Ref / Catalog
1, 3000555
Primary DI / UDI-DI
00810096640048
FDA Product Code
QJR
GMDN Term
Nucleic acid amplification mastermix kit IVD
Device Class
N
GUDID distribution status
Not in Commercial Distribution

Properties

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

Other properties (8)

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