CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT BL-427 BL427

GUDID 00817302021486

METH (Methamphetamine) 2 x 100 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical

• Primary Device ID: 00817302021486
• NIH Device Record Key: 8a15f020-9cfd-49d9-800b-03d4cc93e44d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT BL-427
• Version Model Number: BL427
• Catalog Number: BL427
• 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: true
• 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

Device Dimensions

• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0
• Total Volume: 8 Milliliter
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0
• Total Volume: 8 Milliliter
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0
• Total Volume: 8 Milliliter
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0
• Total Volume: 8 Milliliter
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0
• Total Volume: 8 Milliliter
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0
• Total Volume: 8 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302021486 [Primary]

FDA Product Code

• LAF: GAS CHROMATOGRAPHY, METHAMPHETAMINE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

Devices Manufactured by CAROLINA LIQUID CHEMISTRIES CORPORATION

• 00817302022353 - Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set: 2023-04-04
• 00817302022339 - Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN: 2023-03-20
• 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)