For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.

For the qualitative detection of Plasmodium falciparum (P.f.) and pan
BinaxNOW® Malaria - 665-025

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OAX

Device Name: Plasmodium Spp. Detection Reagents

Device Class: 2

Physical State: In Vitro diagnostic kit

Definition: For the detection of plasmodium spp. Antigens in venous or capillary whole blood. To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plasmodium species.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: In vitro diagnostic immunochromatographic membrane assays or lateral flow assays that uses antibodies to detect specific antigens.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Plasmodium spp. antigens in whole blood

Regulation Number: 866.3402

Third Party Flag: N

Medical Specialty: MI

Device Id: 10811877010378

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A