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Digital LightCycler Analyzer 09274804001

by Roche Molecular Systems, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number07613336175941 UDI-DI Date24 Sep 2026ListedStatusListed GUDID: 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  • Withdrawn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
Digital LightCycler Analyzer
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Ref / Catalog
09274804001
Primary DI / UDI-DI
07613336175941
FDA Product Code
NSU
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Device Class
Class II
Regulation Number
862.2570
GUDID distribution status
In Commercial Distribution

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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