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Amplichek 12000578

by Bio-Rad Laboratories

Amplichek 12000578 is a Class II device made by Bio-Rad Laboratories, granted FDA De Novo DEN150058 on 28 Mar 2016 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00847661005995), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

De Novo DEN150058

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847661005995 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Post-NSE NumberDEN150058 Date28 Mar 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA De Novo DEN150058 decided 28 Mar 2016 Active
  • FDA GUDID UDI-DI 00847661005995 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Granted FDA De Novo DEN150058
  2. Listed FDA GUDID 00847661005995

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

GUDID

Trade name
Amplichek
Generic name
Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Model / Ref / Catalog
12000578
Primary DI / UDI-DI
00847661005995
De Novo Number
FDA product code
PMN
GMDN term
Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Device class
Class II
Regulation number
866.3920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Clostridium difficile nucleic acid IVD, controlMRSA nucleic acid IVD, controlVancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control

Cleared under the same submission (DEN150058)

and 3 more cleared under DEN150058

Similar devices

Other devices filed under FDA product code PMN (Assayed external control material for microbiology nucleic acid amplification (NAT) assays).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)