PHOSPHORUS

Basic Information

• Brand Name: PHOSPHORUS
• Primary DI: 00628063400850
• Version / Model: SK117-20
• Catalog Number: SK117-20
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: ded88408-8e84-416e-a265-7a8d55be43f7

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
CEO	Phosphomolybdate (colorimetric), inorganic phosphorus	Clinical Chemistry	862.1580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59123	Inorganic phosphate (PO43-) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628063400850	GS1

Premarket Submissions

Submission Number	Supplement Number
K974858	000