VITROS Chemistry Products hsCRP Reagent

VITROS Chemistry Products hsCRP Reagent
VITROS - 6801739

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].

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NQD

Device Name: Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Device Class: 2

Physical State: N/A

Definition: In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

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 Id: 10758750006885

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: 20758750006882

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750006885

Package Quantity: 36

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case