Device
Clinical and experimental evidence strongly suggests that circulating antibodies directed against acetylcholine receptor (AChR) and muscle cell antigens are important in the pathog...
Manufacturer
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC.
Model: 5848RL
Catalog: 5848RL
DI: 00845533003483
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Clinical and experimental evidence strongly suggests that circulating antibodies directed against acetylcholine receptor (AChR) and muscle cell antigens are important in the pathogenesis of myasthenia gravis. Several antibody mediated mechanisms have been implanted in the alteration of neuromuscular transmission, including (1) complement mediated destruction of motor and plates with consequent AChR loss, (2) blockage of the AChR active site preventing AChR access, or (3) alteration of AChR turnover. The positive response to thymectomy in patients with a short history of myasthenia gravis (MG) may be due to alteration of thymic cell populations that normally regulate antibody production
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4ada57f2-d7cb-42a2-a359-14ac3cdeb7f2
Distribution Status:
In Commercial Distribution
DUNS Number:
080953946
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00845533003483
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55151
Name: Striated muscle antibody IVD, kit, fluorescent immunoassay
Definition:
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.
FDA Product Codes
None
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature