CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET
• Primary DI: 00817302020175
• Version / Model: ST500
• Catalog Number: ST500
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b275ccd1-7630-410a-b749-f0a9a773cff9

Device Description

Vitamin D-direct w/ cal 1 x 100 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
MRG	SYSTEM, TEST, VITAMIN D	Clinical Chemistry	862.1825	2
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54474	Multiple form 25-hydroxy Vitamin D IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.	No	Active
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302020175	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Milliliter
Device Size Text, specify			Kit contains 1 R1, 1 R2, 1 R3, 1 R4 (diluent), 1 each calibrators, C1, C2, C3, C4,& C5 and 1 package insert.
Total Volume	7.5	Milliliter
Total Volume	17	Milliliter
Total Volume	13	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Reagents, calibrators, diluent and control are stable when stored at 2 to 8°C until the expiration date on the label. After use, the solutions should be kept capped in its reagent bottle.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius