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Acuitas AC042

by Opgen, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number01812125010067 UDI-DI Date25 Oct 2021ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Acuitas
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Ref / Catalog
AC042
Primary DI / UDI-DI
01812125010067
510(k) Number
FDA Product Code
PMY, OOI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Device Class
Class II
Regulation Number
866.1640, 862.2570
GUDID distribution status
Not in Commercial Distribution

Other devices from Opgen, 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