CMA P HRT Test(L) 96

CMA P HRT Test(L) 96 - 5496L

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to striated muscle in a clinical specimen, using a fluorescent immunoassay method. It is used as an aid in the diagnosis of skeletal and cardiac muscle autoimmune disorders such as myasthenia gravis (MG) and inflammatory myopathies, and various autoimmune endocrinopathies.

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: 00813545022877

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