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Vitros 6199337

by Ortho-Clinical Diagnostics

Vitros 6199337 is a Class I device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 24 Oct 2022 (UDI-DI 10758750034321), 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 Number10758750034321 UDI-DI Date24 Oct 2022ListedStatusListed 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  • Withdrawn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
Prolactin IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
6199337
Primary DI / UDI-DI
10758750034321
FDA product code
CFT
GMDN term
Prolactin IVD, kit, chemiluminescent immunoassay
Device class
Class I
Regulation number
862.1625
GUDID distribution status
In Commercial Distribution

Related devices

Category: Prolactin IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under Prolactin IVD, kit, chemiluminescent immunoassay.

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)