Anti-nuclear Antigen (ANA) Screen ELISA

Anti
IMMCO DIAGNOSTICS - 1175

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.

• 96 DETERMINATIONS

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LJM

Device Name: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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: 866.5100

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00845714000218

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