- Physicians Office Resource

The Alethia Malaria External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Malaria or Alethia Malaria PLUS DNA Amplification Assays. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.
Alethia Malaria External Control Kit - 479970

Device Description

A material which is used to verify the performance of an assay 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.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

30.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00840733102165

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

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