The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of Alkaline Phosphatase (ALP) activity in serum or plasma.

The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
ALP - AP2809

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 quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CJE

Device Name: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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: 862.1050

Third Party Flag: Y

Medical Specialty: CH

Device Id: 05055273200300

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