Intended for use as an creatinine standard for standardization or calibration of modified Jaffe or enzymatic creatinine procedures

Intended for use as an creatinine standard for standardization or calibration of modified Jaffe or enzymatic creatinine procedures
POINTE SCIENTIFIC Creatinine Standard - C7513-STD

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CGX

Device Name: Alkaline Picrate, Colorimetry, Creatinine

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: 862.1225

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00811727011015

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