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Bio-Rad Laboratories, Inc.

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Bio-Rad Laboratories, Inc. FDA UDI
Generic Name
Organic solvent metabolite IVD, reagent FDA UDI
Device Name
Substrate for Serology EIA Tests FDA UDI
Model / Reference
25192 FDA UDI
Description
Substrate for Serology EIA Tests FDA UDI

Identifiers

Catalog Number
25192 FDA UDI
Primary DI / UDI-DI
00847865011198 FDA UDI
510(k) Number
K954191 FDA UDI
FDA Product Code
LFZ FDA UDI
GMDN Term
Organic solvent metabolite IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Dimensions & Sizes

Size
Total Volume — 12 Milliliter FDA UDI

Category: Organic solvent metabolite IVD, reagent

Bio-Rad Laboratories, Inc. by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Organic solvent metabolite IVD, reagent.

Cleared under the same submission

K954191 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 15393c70-9822-46bb-8a2d-f4cbaa85a26d 38 fields · synced May 29, 2026