CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D CC204-100-D

GUDID 00817302020151

Lp(a) (Lipoprotein (a) 2 x 60 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

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

• Primary Device ID: 00817302020151
• NIH Device Record Key: 6d9f7b3a-f066-44fb-b866-4c23577cf40e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D
• Version Model Number: CC204-100-D
• Catalog Number: CC204-100-D
• 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: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302020151 [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

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