For the quantitative determination of human rheumatoid factor (RF) in serum and plasma by immunoturbidimetric assay.

For the quantitative determination of human rheumatoid factor (RF) in serum and plasma by immunoturbidimetric assay.
K-ASSAY® RF Reagent (Ver.2) - KAI-230

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DHR

Device Name: System, Test, Rheumatoid Factor

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: 866.5775

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00816426021457

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