The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection. Alethia Malaria assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assay does not distinguish between Plasmodium species. Alethia Malaria is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection. Alethia Malaria assay utilizes loop
Alethia Malaria - 480925

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen, using a nucleic acid technique (NAT).

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: 00840733102240

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