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Vitros 6199921

by Ortho-Clinical Diagnostics

Vitros 6199921 is a device classified as Not classified made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 22 Mar 2021 (UDI-DI 10758750033379), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10758750033379 UDI-DI Date22 Mar 2021ListedStatusListed 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  • Withdrawn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
Vitros
Generic name
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Model / Ref / Catalog
6199921
Primary DI / UDI-DI
10758750033379
FDA product code
QKO
GMDN term
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Device class
N
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Similar devices

Other devices filed under FDA product code QKO (Reagent, coronavirus serological).

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)