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NeuMoDx™ 288 Molecular System 500100

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 Number10814278020014 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  • Withdrawn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
NeuMoDx™ 288 Molecular System
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Ref / Catalog
500100
Primary DI / UDI-DI
10814278020014
FDA Product Code
OOI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Device Class
Class II
Regulation Number
862.2570
GUDID distribution status
Not in Commercial Distribution
Size
Depth — 109.2 Centimeter
Width — 182.9 Centimeter
Height — 190.5 Centimeter

Other devices from Neumodx Molecular, Inc.

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No