Pointe Scientific, Inc. Creatine Kinase Reagent is for the quantitative determination of creatine kinase activity in serum on Olympus Analyzers.
4 x 60ml, 4 x 15ml
Pointe Scientific, Inc. Creatine Kinase - OC922-300
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen, using an enzyme spectrophotometry method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CGS
Device Name: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
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: 862.1215
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00811727015006
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