The C
C-Reactive Protein HS ELISA - EIA-3954
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a fluorescent immunoassay method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.
Environmental Conditions
No Data Available
Device Sizes
- Stop Solution
- TMB
- Total Volume: 50 Milliliter
- Sample Diluent
- Total Volume: 12 Milliliter
- Total Volume: 1 Milliliter
- Standards
- Total Volume: 11 Milliliter
- Conjugate Reagent
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: 00840239039545
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