ASI Color Staph Latex Test

Basic Information

• Brand Name: ASI Color Staph Latex Test
• Primary DI: 00816057021826
• Version / Model: NC-285-050
• Catalog Number: NC-285-050
• Company Name: ARLINGTON SCIENTIFIC, INC.
• Labeler DUNS: 785966607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-19
• Public Version: 1
• Public Version Date: 2023-12-27
• Public Version Status: New
• Public Device Record Key: 80fe0e5a-8f62-413c-8bdf-6ff594198a58

Device Description

ASI Color Staph Latex Test 50 test kit

Device Characteristics

• Single Use: No
• 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: 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
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51659	Staphylococcus aureus culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from 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	00816057021826	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K830783	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Tests

Storage Conditions

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