The Cystatin C Control is intended for use with in vitro diagnostic assays for the quantitative determination of Cystatin C. Cystatin C Control is assayed with target values and it is suitable for use on automated analysers.
CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) - CYS5019
Device Description
A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.
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: JJX
Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 862.1660
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 05055273207415
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