R. STM/STR/HRT Pack 4W

Basic Information

• Brand Name: R. STM/STR/HRT Pack 4W
• Primary DI: 00813545020071
• Version / Model: 1381
• Catalog Number: 1381
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 442aba44-2de2-4638-9899-a55566ae3558

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
55151	Striated muscle 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 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	Active
31468	Smooth muscle antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to smooth muscle in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545020071	GS1

Customer Contacts

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