Pointe Creatinine Reagent packaged for use on the Mindray BA800. 6 x 67ml R1, 5 x 17ml R2. For the quantitative determination of creatinine in serum. For in vitro diagnostic use only.
Pointe Creatinine Reagent - 16-C7539-487
Device Description
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.
Environmental Conditions
- 30.00
- 15.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00811727016119
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