ASA(ME)96 Test(L)

ASA(ME)96 Test(L) - 5396L

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to skin in a clinical specimen, using a fluorescent immunoassay method. This test is typically used to aid the diagnosis of skin disorders (e.g., autoimmune bullous dermatoses such as pemphigus vulgaris, paraneoplastic pemphigus, or dermatitis herpetiformis); antibodies detected are typically directed at structural proteins of the skin and/or superficial mucosa (e.g., gliadin, desmoglein, collagen, endomysium).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DBL

Device Name: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, 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: 866.5660

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00813545022839

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