SAS RF-Latex

Basic Information

• Brand Name: SAS RF-Latex
• Primary DI: 00780311000875
• Version / Model: 098050
• Company Name: SA SCIENTIFIC, LTD.
• Labeler DUNS: 122092117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-02
• Public Version: 1
• Public Version Date: 2018-12-03
• Public Version Status: New
• Public Device Record Key: 71eba0ee-6c42-4930-87d2-b0007bdc90cf

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
54845	Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with rheumatoid arthritis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrulline peptide.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00780311000875	GS1