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Biomeme Franklin three9 Real-Time PCR Thermocycler 2.8

by Biomeme, Inc. 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810096640123 UDI-DI Date2 Dec 2022ListedStatusListed 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  • Withdrawn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
Biomeme Franklin three9 Real-Time PCR Thermocycler
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Ref / Catalog
2.8, 1000018
Primary DI / UDI-DI
00810096640123
FDA Product Code
QJR
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Device Class
N
GUDID distribution status
Not in Commercial Distribution

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

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