pHix

Basic Information

• Brand Name: pHix
• Primary DI: 10888234000501
• Version / Model: 0005070
• Catalog Number: 0005070
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 41afcc7b-b00f-4efb-a9d2-aca7a4b97400

Device Description

This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
JCC	Ph Buffer	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42693	pH-adjusted buffer solution IVD	A pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000501	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius