CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STD

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STD
• Primary DI: 00817302024340
• Version / Model: CC618-STD
• Catalog Number: CC618-STD
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-19
• Public Version: 1
• Public Version Date: 2022-08-29
• Public Version Status: New
• Public Device Record Key: 8b31c3f9-4d21-4bb9-a154-c3c291d8e6b8

Device Description

IRON STANDARD (FESTD)

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: Yes
• 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
JIS	Calibrator, primary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54760	Iron IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of iron in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302024340	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter
Device Size Text, specify			Kit contains 1 bottle

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius