For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.

For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
AMYLASE (CNPG3) Reagent Set - 4 x 120 mL

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 amylase isoenzymes in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CIJ

Device Name: Saccharogenic, Amylase

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1070

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00812137011879

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

Device Id: 00812137012234

Device Type: Unit of Use

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