Endomysium (Primate esophagus)

Basic Information

• Brand Name: Endomysium (Primate esophagus)
• Primary DI: 00845533002011
• Version / Model: 5396EL
• Catalog Number: 5396EL
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-17
• Public Version: 1
• Public Version Date: 2025-10-27
• Public Version Status: New
• Public Device Record Key: 01dbbeb8-39a0-4524-a950-c090ff43727f

Device Description

Indirect fluorescent assay (IFA) for anti-endomysial antibodies has proven to be a good method to screen for Celiac disease. Endomysial antibodies of the IgA subclass (IgA EmA) react with the reticulin component of the endomysium of the smooth muscle in primate esophagus tissue. These antibodies can be found in 60-70% of patients with Dermatitis herpetiformis (DH) on a non-restricted diet and in almost 100% of patients with Celiac disease (CD) and gluten-sensitivity enteropathy with partial or sub totaling villous atrophy. There is a small percentage of IgG EmA that will be negative IgA when screened. A negative result exhibited by a patient with overt clinical symptoms may need to be considered for IgG testing. It is recommended to perform an anti-Gliadin test in order to reach the maximum specificity of the test. It has been demonstrated that serum IgA endomysial antibodies were found in the majority (87%) of patients with untreated Celiac disease and approximately 70% of anti-Gliadin (IgA AGA) positive patients. The R1 anti-Reticulin (R1-ARA) appears to be a less reliable marker with less than 50% being positive. These findings were based on the same patient population. It should be noted that a strict adherence to a gluten-free diet will greatly effect the antibody results in most patients. IgA AGA and R1-ARA will normally disappear after one year while IgA EmA may persist at a lower titer. In this way the test may have prognostic value in monitoring strict adherence to diet.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54905	Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845533002011	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius