CK (Creatine Kinase) 3 x 100 tests

CK (Creatine Kinase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORP.® CK RGT. KIT BL-207 - BL207

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

Reagent is stable when stored at 2-8° C until expiration date

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 20 Milliliter

Total Volume: 5 Milliliter

Kit contains 3 R1 and 3 R2 bottles and 1 package insert

Total Volume: 20 Milliliter
Total Volume: 5 Milliliter
Kit contains 3 R1 and 3 R2 bottles 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 Identifiers

Device Id: 00817302020496

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