PHOENIX DIAGNOSTICS, INC.

Basic Information

• Brand Name: PHOENIX DIAGNOSTICS, INC.
• Primary DI: 00853366007189
• Version / Model: 16-226
• Company Name: PHOENIX DIAGNOSTICS, INC.
• Labeler DUNS: 606814960
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-26
• Public Version: 4
• Public Version Date: 2020-03-30
• Public Version Status: Update
• Public Device Record Key: 72225976-1748-49e3-b5fc-a0ef8e4a6c6c

Device Description

ISE Internal Ref Sol for Roche / Hitachi 911 Series Chemistry Systems

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59238	Ion selective electrode (ISE) reference solution IVD, reagent	A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853366007189	GS1
Package	10853366007186	GS1	Case	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K013451	000