The ANA Screen ELISA test system is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to the enclosed instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns.

The ANA Screen ELISA test system is a qualitative screening assay designed to detect anti
ANA Screen IgG ELISA - EIA-2773

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 an enzyme immunoassay (EIA) method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LLL

Device Name: Extractable Antinuclear Antibody, Antigen And Control

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: 00840239027733

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