Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays.

Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays.
ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) - LV10366

A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJY

Device Name: Multi-Analyte Controls, All Kinds (Assayed)

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 05055273216486

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