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NeuMoDxTM LDT Master Mix, DNA 210100

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 Number10814278020199 UDI-DI Date29 Mar 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  • Withdrawn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 LDT Master Mix, DNA
Generic Name
Nucleic acid amplification mastermix reagent IVD
Model / Ref / Catalog
210100
Primary DI / UDI-DI
10814278020199
FDA Product Code
PPM
GMDN Term
Nucleic acid amplification mastermix reagent IVD
Device Class
Class I
Regulation Number
864.4010
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
  • Manufacturing Date

Other properties (7)

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