CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909 DT909

GUDID 00817302024500

ISE CALIBRATOR 2

CAROLINA LIQUID CHEMISTRIES CORPORATION

Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 00817302024500
• NIH Device Record Key: 62023dd3-7a9c-4fd4-898d-cf5537889ea3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909
• Version Model Number: DT909
• Catalog Number: DT909
• Company DUNS: 962385787
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com

Device Dimensions

• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter
• Device Size Text, specify: 0
• Total Volume: 10 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302024500 [Primary]

FDA Product Code

• JIX: Calibrator, multi-analyte mixture

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: 2022-08-29
• Device Publish Date: 2022-08-19

Devices Manufactured by CAROLINA LIQUID CHEMISTRIES CORPORATION

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• 00817302022346 - Carolina Liquid Chemistries Corp. Fentanyl Detection Kit: 2023-03-20
• 00817302024678 - CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445: 2022-12-12 Oxidant Reagent (CC445)
• 00817302024654 - Caldon Biotech Aldolase Reagent: 2022-12-08 Aldolase
• 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)