The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C
CRP Calibrator Set - 5 x 2mL
Device Description
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].
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: DCK
Device Name: C-Reactive Protein, Antigen, Antiserum, And Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5270
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00812137012142
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
Device Id: 00812137012432
Device Type: Unit of Use
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