Filaria Antibody 96 Tests - FI-96
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Wuchereria bancrofti and Brugia malayi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Wuchereria bancrofti and Brugia malayi, the parasitic nematodes associated with filariasis.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LIB
Device Name: Device, General Purpose, Microbiology, Diagnostic
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.2660
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00813545025427
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