DIASTAT anti-Ro (SS-A)

Basic Information

• Brand Name: DIASTAT anti-Ro (SS-A)
• Primary DI: 07340058410004
• Version / Model: FARO300
• Catalog Number: FARO300
• Company Name: Euro-Diagnostica AB
• Labeler DUNS: 559894501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2db71ebb-326c-4c82-9c42-8bb43586fa15

Device Characteristics

• Single Use: No
• 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: 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
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55129	SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340058410004	GS1

Premarket Submissions

Submission Number	Supplement Number
K905194	000