Skip to content

NeuMoDxTM GBS Test Strip 200400

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 Number10814278020045 UDI-DI Date3 Apr 2019ListedStatusListed 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  • Withdrawn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
NeuMoDxTM GBS Test Strip
Generic Name
Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
Model / Ref / Catalog
200400
Primary DI / UDI-DI
10814278020045
FDA Product Code
NJR
GMDN Term
Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
Device Class
Class I
Regulation Number
866.3740
GUDID distribution status
Not in Commercial Distribution

Other devices from Neumodx Molecular, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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