CK (Creatine Kinase) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORP.™ CK CREATINE KINASE REAGENT CC207 - CC207
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.
Environmental Conditions
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Total Volume: 60 Milliliter
- Total Volume: 10 Milliliter
- Kit contains 2 reagent cartridges and 1 package insert
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: 00817302020519
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