The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
AST - AS1267

Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Stable for 14 days at +2 to +8°C or 24 hours at +15 to +25°C once reconstituted.

Storage Environment Temperature - Degrees Celsius

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: CIT

Device Name: Nadh Oxidation/Nad Reduction, Ast/Sgot

Device Class: 2

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: 862.1100

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 05055273200430

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