Vitros

FDA UDI

Class I (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name: VITROS FDA UDI
Generic Name: Ferritin IVD, control FDA UDI
Device Name: VITROS Immunodiagnostic Products Anemia Controls FDA UDI
Model / Reference: 1619360 FDA UDI
Description: VITROS Immunodiagnostic Products Anemia Controls FDA UDI

Identifiers

Catalog Number: 1619360 FDA UDI
Primary DI / UDI-DI: 10758750009411 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Ferritin IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vitamin B12 IVD, control Ferritin IVD, control

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

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Alinity — ABBOTT IRELAND · Class I
Atellica IM Fer MCM — Siemens Healthcare Diagnostics · Class I
Diazyme — Diazyme Laboratories, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ortho-Clinical Diagnostics

Sources (1)

FDA UDI d6748ad9-291b-4f03-b63c-05d820b69057 35 fields · synced May 30, 2026