Kallestad pANCA Positive Control, 0.5 mL

Kallestad pANCA Positive Control, 0.5 mL
Kallestad ANCA - 29401

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen.

• Total Volume: 0.5 Milliliter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MOB

Device Name: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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: 866.5660

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00847817016097

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