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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
Phosphoric acid stop solution reagent IVD FDA UDI
Device Name
Stop Reagent for Serology EIA Tests FDA UDI
Model / Reference
25191 FDA UDI
Description
Stop Reagent for Serology EIA Tests FDA UDI

Identifiers

Catalog Number
25191 FDA UDI
Primary DI / UDI-DI
00847865011181 FDA UDI
510(k) Number
K954191 FDA UDI
FDA Product Code
LFZ FDA UDI
GMDN Term
Phosphoric acid stop solution reagent IVD 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: Phosphoric acid stop solution reagent IVD

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

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 a20444e5-9f00-4802-82dd-ad1013fa6ee8 38 fields · synced May 31, 2026