CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 SERUM CAL KIT Product No. 28200

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 SERUM CAL KIT Product No. 28200
• Primary DI: 00817302022261
• Version / Model: 28200
• Catalog Number: 28200
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ae8f2a8a-b959-4005-8adc-a22901d31167
• Distribution End Date: 2017-04-10

Device Description

Serum Calibrator

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
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52851	Glucose/ketone/lipid profile IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302022261	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter
Device Size Text, specify			Kit contains 6 ca-5 bottles, 1 reagent package insert and 1 setpoint package insert

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Unreconstituted serum is stable up to expiration date.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Once reconstituted, the components of the Calibration Sera are stable for 8 hours at 25°C, 7 days at 2-8°C and 1 month at -20°C when frozen once.