cobas e 402 analytical unit

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: cobas e 402 analytical unit FDA UDI
Generic Name: Chemiluminescent immunoassay analyser IVD FDA UDI
Model / Reference: 09793020001 FDA UDI

Identifiers

Catalog Number: 09793020001 FDA UDI
Primary DI / UDI-DI: 07613336220139 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

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

FDA UDI

Category: Chemiluminescent immunoassay analyser IVD

cobas e 402 analytical unit by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemiluminescent immunoassay analyser IVD.

ThunderBolt EIA (CLIA) — Gold Standard Diagnostics, LLC · Class I
Alinity — Abbott Laboratories, Inc. · Class I
ARCHITECT — Abbott Laboratories, Inc. · Class I
Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
ARCHITECT — Abbott Laboratories, Inc. · Class I
Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
Alinity — Abbott Laboratories, Inc. · N
VITROS — Ortho-Clinical Diagnostics · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Roche Diagnostics Corp.

Sources (1)

FDA UDI 1488f547-48e6-4018-8cd3-b06daeca066b 33 fields · synced May 30, 2026