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Vitros

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS FDA UDI
Generic Name
Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
VITROS Chemistry Products TRFRN Reagent FDA UDI
Model / Reference
6801767 FDA UDI
Description
VITROS Chemistry Products TRFRN Reagent FDA UDI

Identifiers

Catalog Number
6801767 FDA UDI
Primary DI / UDI-DI
10758750001354 FDA UDI
FDA Product Code
DDG FDA UDI
GMDN Term
Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5880 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

No

FDA UDI

Category: Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 031e0ac9-e432-4be2-92cb-f0bf7ec31ac2 35 fields · synced Jun 8, 2026