Skip to content

Fast PCR Base Station FP-BS1

by Autonomous Medical Devices Incorporated

Listed FDA GUDID listing, no authorization on record

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 Number00850025770002 UDI-DI Date26 Aug 2026ListedStatusListed GUDID: 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  • Withdrawn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
Fast PCR Base Station
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Ref / Catalog
FP-BS1, AMDI-0017
Primary DI / UDI-DI
00850025770002
510(k) Number
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
In Commercial Distribution

Related devices

Cleared under the same submission (K252932)

Show all (10)

Other devices from Autonomous Medical Devices Incorporated

See all devices from Autonomous Medical Devices Incorporated →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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