CMA RT HRT Test(L) 96 - 5496RL
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00813545022884
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