ASI RF Direct Slide Tests for Export

Basic Information

• Brand Name: ASI RF Direct Slide Tests for Export
• Primary DI: 00816057020478
• Version / Model: NC-700025DC-E
• Catalog Number: NC-700025DC-E
• Company Name: ARLINGTON SCIENTIFIC, INC.
• Labeler DUNS: 785966607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d25c8d9e-f495-4a22-8886-7d6f721eb00e

Device Description

Detection of Rheumatoid Factor

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
DHR	System, Test, Rheumatoid Factor	Immunology	866.5775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55112	Rheumatoid factor IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816057020478	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K821319	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			25 Tests

Storage Conditions

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