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Vidas® Tbi (Gfap, Uch-L1)

by Biomerieux, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 1 Jun 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 1 Jun 2026. What this means

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03573026626891 UDI-DI Date31 Oct 2024ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 1 Jun 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multiple traumatic brain injury marker IVD, kit, fluorescent immunoassay
Model / Reference
VIDAS® TBI (GFAP, UCH-L1)
Primary DI / UDI-DI
03573026626891
510(k) Number
FDA Product Code
QAT
GMDN Term
Multiple traumatic brain injury marker IVD, kit, fluorescent immunoassay
Device Class
Class II
Regulation Number
866.5830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple traumatic brain injury marker IVD, kit, fluorescent immunoassay

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Properties

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

Other properties (10)

  • Sterile: No
  • Single Use: 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