CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 BL204

GUDID 00817302020137

Lp(a) (Lipoprotein (a) 2 x 130 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA) LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA) LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00817302020137
• NIH Device Record Key: e99c90c3-82ef-410c-b96d-1ba99b975853
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204
• Version Model Number: BL204
• Catalog Number: BL204
• 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

Device Dimensions

• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable to expiration date when stored at 2 to 8°C
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable to expiration date when stored at 2 to 8°C
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable to expiration date when stored at 2 to 8°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302020137 [Primary]

FDA Product Code

• DFC: LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL

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

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• 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)