Evolis

FDA UDI

Class I (US FDA UDI)

by Bio-Rad

Identity

Trade Name: EVOLIS FDA UDI
Generic Name: Enzyme immunoassay (EIA) analyser IVD FDA UDI
Device Name: EVOLIS FDA UDI
Model / Reference: 89601 FDA UDI
Description: EVOLIS FDA UDI

Identifiers

Catalog Number: 89601 FDA UDI
Primary DI / UDI-DI: 03610520013328 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Enzyme immunoassay (EIA) 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Enzyme immunoassay (EIA) analyser IVD

Evolis by Bio-Rad — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Bio-Rad

Sources (1)

FDA UDI 630d0998-8a67-41c9-a014-100548a4473d 37 fields · synced Jun 8, 2026