An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and plasma.
ALT - AL3875
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen, using an enzyme spectrophotometry method.
Environmental Conditions
- Reagent is stable for 7 days at +2 to +8ºC
- 8.00
- 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: CKA
Device Name: Nadh Oxidation/Nad Reduction, Alt/Sgpt
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: 862.1030
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 05055273200225
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