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BinaxNOW® Malaria

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
BinaxNOW® Malaria FDA UDI
Generic Name
Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens. FDA UDI
Model / Reference
665-000 FDA UDI
Description
For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010361 FDA UDI
510(k) Number
DEN070006 FDA UDI
FDA Product Code
OAX FDA UDI
GMDN Term
Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical 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

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

Yes

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

Category: Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical

BinaxNOW® Malaria by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical.

Cleared under the same submission

DEN070006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI b4ba3851-5d29-482b-8ca3-878bf855effe 34 fields · synced May 31, 2026