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NeuMoDx SARS-CoV-2 Test Strip 300800

by Neumodx Molecular, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10814278021264 UDI-DI Date23 Apr 2020ListedStatusListed 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  • Withdrawn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
NeuMoDx SARS-CoV-2 Test Strip
Generic Name
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
300800
Primary DI / UDI-DI
10814278021264
FDA Product Code
QJR
GMDN Term
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
N
GUDID distribution status
Not in Commercial Distribution

Other devices from Neumodx Molecular, Inc.

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Manufacturing Date: No