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Vitros 1920115

by Ortho-Clinical Diagnostics

Vitros 1920115 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 26 Aug 2016 (UDI-DI 10758750000258), 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 Number10758750000258 UDI-DI Date26 Aug 2016ListedStatusListed 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  • Withdrawn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
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
1920115
Primary DI / UDI-DI
10758750000258
FDA product code
DHX
GMDN term
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
866.6010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay.

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)