CRPhsWR (C
Carolina Liquid Chemistries CRPhsWR - AU-645B
Device Description
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is 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
- Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Kit contains 3 R1 bottles and 3 R2 bottles
- Total Volume: 18 Milliliter
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: 00817302022445
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