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
- 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 IdentifiersDevice 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