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NeuMoDx™ Viral Lysis Buffer 401600

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 Number10814278021257 UDI-DI Date20 Mar 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  • Withdrawn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™ Viral Lysis Buffer
Generic Name
Nucleic acid sequencing reagent kit IVD
Model / Ref / Catalog
401600
Primary DI / UDI-DI
10814278021257
FDA Product Code
PPM
GMDN Term
Nucleic acid sequencing reagent kit IVD
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
Not in Commercial Distribution
Size
Total Volume — 1 Liter

Other devices from Neumodx Molecular, Inc.

Properties

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

Other properties (10)

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