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Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10) AMDI-0066

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 Number00850025770156 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  • Withdrawn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 Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)
Generic Name
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Reference
AMDI-0066
Primary DI / UDI-DI
00850025770156
510(k) Number
FDA Product Code
QOF
GMDN Term
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.3981
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252932)

Show all (10)

Other devices from Autonomous Medical Devices Incorporated

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No