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InteliQ 12004310

by Bio-Rad Laboratories

InteliQ 12004310 is a Class I device made by Bio-Rad Laboratories, listed in FDA GUDID since 14 Sep 2020 (UDI-DI 03610520267219), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03610520267219 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
InteliQ
Generic name
Homocysteine IVD, control
Model / Ref / Catalog
12004310
Primary DI / UDI-DI
03610520267219
FDA product code
JJX
GMDN term
Homocysteine IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)