Vitros

FDA UDI

Class I (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name: VITROS FDA UDI
Generic Name: Chemiluminescent immunoassay analyser IVD FDA UDI
Device Name: VITROS 3600 Immunodiagnostic System FDA UDI
Model / Reference: 6802783 FDA UDI
Description: VITROS 3600 Immunodiagnostic System FDA UDI

Identifiers

Catalog Number: 6802783 FDA UDI
Primary DI / UDI-DI: 10758750002979 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Chemiluminescent immunoassay analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 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

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chemiluminescent immunoassay analyser IVD

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

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ARCHITECT — Abbott Laboratories, Inc. · Class I
Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
Alinity — Abbott Laboratories, Inc. · N

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 7387a125-fd85-448c-adee-468a39f4504c 35 fields · synced May 30, 2026