Pr 4100

FDA UDI

Class I (US FDA UDI)

by Bio-Rad

Identity

Trade Name: PR 4100 FDA UDI
Generic Name: Enzyme immunoassay (EIA) analyser IVD FDA UDI
Device Name: PR 4100 FDA UDI
Model / Reference: 91587 FDA UDI
Description: PR 4100 FDA UDI

Identifiers

Catalog Number: 91587 FDA UDI
Primary DI / UDI-DI: 03610520013571 FDA UDI
FDA Product Code: JJQ FDA UDI
GMDN Term: Enzyme immunoassay (EIA) analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2300 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

Pr 4100 by Bio-Rad — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enzyme immunoassay (EIA) analyser IVD.

ORTHO — Ortho-Clinical Diagnostics · N
EUROLabWorkstation ELISA — EUROIMMUN Medizinische Labordiagnostika AG · Class I
ORTHO — Ortho-Clinical Diagnostics · N
ThunderBolt EIA (CLIA) — Gold Standard Diagnostics, LLC · Class I
CHORUS TRIO — DIESSE DIAGNOSTICA SENESE SPA · Class I
ORTHO — Ortho-Clinical Diagnostics · N
Bolt (CLIA) — Gold Standard Diagnostics, LLC · Class I
UNION Immune Analyzer — Shenzhen YHLO Biotech Co., Ltd. · 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: Bio-Rad

Sources (1)

FDA UDI 9f45c7a0-5dab-4947-97da-25c6685dd4b2 37 fields · synced Jun 8, 2026