ISE ELECTROLYTE REFERENCE 88811

Basic Information

• Brand Name: ISE ELECTROLYTE REFERENCE 88811
• Primary DI: 00817302020670
• Version / Model: 88811
• Catalog Number: 88811
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: 2a07163a-ff4c-45d1-821d-71368a6160b8

Device Description

ISE (Electrolytes) Reference - CX3 Reagent 1 x 2000 mL

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
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE	Clinical Chemistry	862.1160	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	00817302020670	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Kit contains 1 R1 and 1 package insert
Total Volume	2000	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable when stored at 8-30° C until expiration date
• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable on board a clinical analyzer for 30 days
• Type: Storage Environment Temperature
• Temperature Range: 8 – 30 Degrees Celsius