Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use only. 1 x 125 ml

Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use only. 1 x 125 ml
Pointe Scientific, Inc. - 13-C7539-R2-125

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: 00811727014108

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