CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667
• Primary DI: 00817302022667
• Version / Model: CC667
• Catalog Number: CC667
• 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: 2018-08-27
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: cd510ead-9dd9-40db-b56d-646bdebe52eb
• Distribution End Date: 2018-08-27

Device Description

LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
LBR	LDL & VLDL PRECIPITATION, HDL	Clinical Chemistry	862.1475	1
MRR	SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53395	Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302022667	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	19	Milliliter
Total Volume	52	Milliliter
Total Volume	3	Milliliter
Device Size Text, specify			Kit contains 2 filled reagent cartridges 1 filled HDL/LDL Calibrator bottle 2 package inserts with LDL 1 and LDL 2 User Defined Parameters printed on the back, and 1 HDL/LDL Calibrator package insert

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
• Type: Special Storage Condition, Specify
• Special Conditions: Onboard the SYNCHRON: LDL is stable for 30 days.