CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 100 tests

CRPhsWR (C
CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W WIDE RANGE CC645 - CC645

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 spectrophotometry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.

Environmental Conditions

Special Storage Condition, Specify

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

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Kit contains 2 reagent cartridges, 1 package insert and 2 user defined parameters

Total Volume: 11 Milliliter

Total Volume: 20.5 Milliliter

Kit contains 2 reagent cartridges, 1 package insert and 2 user defined parameters
Total Volume: 11 Milliliter
Total Volume: 20.5 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 Identifiers

Device Id: 00817302022087

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