Enhanced Anti-RNA POL lll Antibody ELISA

Enhanced Anti
Immco Diagnostics, Inc - 5170

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-RNA polymerase III antibodies (anti-Pol III) in a clinical specimen, using an enzyme immunoassay (EIA) method.

• 96 determinations

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NYO

Device Name: Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Device Class: 2

Physical State: Antibody ELISA kit, Antigen and Controls

Definition: The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The ELISA test result aids in the diagnosis of Systemic Sclerosis (SSc)

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Blood Serum

Regulation Number: 866.5100

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00845714004827

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