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Fast PCR Mini Respiratory Panel External Control Kits (10 Pos + 10 Neg) AMDI-0045

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 Number00850025770057 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  • Withdrawn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 External Control Kits (10 Pos + 10 Neg)
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, control
Model / Reference
AMDI-0045
Primary DI / UDI-DI
00850025770057
510(k) Number
FDA Product Code
PMN
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, control
Device Class
Class II
Regulation Number
866.3920
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