PHOENIX DIAGNOSTICS, INC.

Basic Information

• Brand Name: PHOENIX DIAGNOSTICS, INC.
• Primary DI: 00853366007158
• Version / Model: 16-201
• 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: 5
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 12b2eb0a-9b04-4015-9dfd-22b967fe9142

Device Description

ISE Diluent for Roche / Hitachi 700 & 900 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
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853366007158	GS1
Package	10853366007155	GS1	Case	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K013451	000