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Vitros

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS FDA UDI
Generic Name
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
VITROS Immunodiagnostic Products CEA Reagent Pack FDA UDI
Model / Reference
1920115 FDA UDI
Description
VITROS Immunodiagnostic Products CEA Reagent Pack FDA UDI

Identifiers

Catalog Number
1920115 FDA UDI
Primary DI / UDI-DI
10758750000258 FDA UDI
FDA Product Code
DHX FDA UDI
GMDN Term
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA UDI 7f3d1d52-ed92-4cb5-8fc6-591a922de58c 35 fields · synced May 30, 2026