Carolina Liquid Chemistries Corp. Fentanyl Detection Kit

Basic Information

• Brand Name: Carolina Liquid Chemistries Corp. Fentanyl Detection Kit
• Primary DI: 00817302022346
• Version / Model: CLCF65025
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-10
• Public Version: 1
• Public Version Date: 2023-03-20
• Public Version Status: New
• Public Device Record Key: 369ed730-56b9-4d9d-adc4-db428d95bc8a

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
DJG	Enzyme immunoassay, opiates	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64153	Fentanyl IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302022346	GS1

Premarket Submissions

Submission Number	Supplement Number
K220046	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius