ASA(ME)48 Test(L)

Basic Information

• Brand Name: ASA(ME)48 Test(L)
• Primary DI: 00813545022808
• Version / Model: 5348L
• Catalog Number: 5348L
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2019-01-08
• Public Version Status: Update
• Public Device Record Key: 2a603078-a68e-4393-ba55-f99cf5dd3a9f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55139	Skin antibody IVD, kit, fluorescent immunoassay	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545022808	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]