Non-Esterified Fatty Acids (NEFA) - FA115
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-esterified fatty acid in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is used to aid diagnosis of various metabolic conditions (e.g., diabetes).
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: JLG
Device Name: Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1290
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 05055273203066
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