Anti-CCP Control Set

Anti
BioPlex 2200 - 6633230

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide (CCP) in a clinical specimen.

• Total Volume: 1.5 Milliliter
• 4 Vials

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJY

Device Name: Multi-Analyte Controls, All Kinds (Assayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

Code: NHX

Device Name: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Device Class: 2

Physical State: N/A

Definition: The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.

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

Code: JIX

Device Name: Calibrator, Multi-Analyte Mixture

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1150

Third Party Flag: N

Medical Specialty: CH

Device Id: 00847865000833

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