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Bio-Rad

FDA UDI

Class II (US FDA UDI)

by Clark Laboratories, Inc.

Identity

Trade Name
Bio-Rad FDA UDI
Generic Name
Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Malaria EIA Test Kit (Non-US Sales only) FDA UDI
Model / Reference
72526 FDA UDI
Description
Malaria EIA Test Kit (Non-US Sales only) FDA UDI

Identifiers

Catalog Number
72526 FDA UDI
Primary DI / UDI-DI
05391516746724 FDA UDI
FDA Product Code
OAX FDA UDI
GMDN Term
Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3402 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clark Laboratories, Inc.

Sources (1)

  • FDA UDI 7545822b-f9a9-4056-81cf-0b1564aa74c2 36 fields · synced May 30, 2026