Pointe Creatinine reagent packaged for use on the BS480 analyzer. 6x60mL, 6x12mL Kit. For the quantitative determination of creatinine in serum. For in vitro diagnostic use only.

Pointe Creatinine reagent packaged for use on the BS480 analyzer. 6x60mL, 6x12mL Kit. For the quantitative determination of creatinine in serum. For in vitro diagnostic use only.
Pointe Creatinine for BS480 - 14-C7539-432

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is 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: 00811727015808

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