The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.

The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
CK NAC - CK3812

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

Special Storage Condition, Specify

Stable for 3 weeks in the instrument at approximately +10°C or 3 days at +15 to +25°C once reconstituted.

Storage Environment Temperature - Degrees Celsius

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 Identifiers

Device Id: 05055273201482

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