Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428 DT428

GUDID 00817302022292

Fentanyl Enzyme Immunoassay

CAROLINA LIQUID CHEMISTRIES CORPORATION

Fentanyl IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00817302022292
• NIH Device Record Key: fc318dd7-acb8-4f31-a6ce-52f85514ac27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428
• Version Model Number: DT428
• Catalog Number: DT428
• Company DUNS: 962385787
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com

Device Dimensions

• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302022292 [Primary]

FDA Product Code

• DJG: Enzyme immunoassay, opiates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

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• 00817302022346 - Carolina Liquid Chemistries Corp. Fentanyl Detection Kit: 2023-03-20
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• 00817302024661 - Caldon Biotech Serum Aldolase Controls: 2022-12-08 Aldolase Controls
• 00817302024647 - CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240: 2022-10-26 Alkaline Aminotransferase (ALT) (GPT) Reagent
• 00817302024104 - CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220: 2022-08-29 Magnesium Arsenazo Reagent (MG)