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FREND ImmunoAssay Multi FRCK-IAM

by NanoEnTek, Inc.

Listed FDA GUDID listing, no authorization on record

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809317541365 UDI-DI Date1 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
FREND ImmunoAssay Multi
Generic Name
Immunoassay instrument/analyser general performance control kit IVD
Model / Ref / Catalog
FRCK-IAM
Primary DI / UDI-DI
08809317541365
GMDN Term
Immunoassay instrument/analyser general performance control kit IVD
GUDID distribution status
In Commercial Distribution

Other devices from NanoEnTek, Inc.

See all devices from NanoEnTek, Inc. →

Properties

  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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