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Vitros 6923434

by Ortho-Clinical Diagnostics

Vitros 6923434 is a Class I device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 26 Aug 2026 (UDI-DI 10758750035823), 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 Number10758750035823 UDI-DI Date26 Aug 2026ListedStatusListed 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  • Withdrawn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
Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
6923434
Primary DI / UDI-DI
10758750035823
FDA product code
JJX
GMDN term
Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)