Reference Solution

Basic Information

• Brand Name: Reference Solution
• Primary DI: 00657498001783
• Version / Model: A469-99
• Catalog Number: A469-99
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2021-03-31
• Public Version Status: Update
• Public Device Record Key: 69075c26-387f-4e13-999e-b18ca0fc2c9e
• Distribution End Date: 2021-03-31

Device Description

To provide constant electrical potential through the reference electrode on the ISE module of the Roche Cobas Chemistry Analyzer.

Device Characteristics

• Single Use: Yes
• 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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

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	00657498001783	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius