CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635 CC635

GUDID 00817302020939

C4 (Complement 4) 2 x 60 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Immunohistochemistry negative control (normal animal serum) IVD

• Primary Device ID: 00817302020939
• NIH Device Record Key: 7c32e8cb-f359-4462-915d-252616bcbb61
• Commercial Distribution Discontinuation: 2018-08-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635
• Version Model Number: CC635
• Catalog Number: CC635
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302020939 [Primary]

FDA Product Code

• DBI: COMPLEMENT C4, 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: 3
• Public Version Date: 2018-08-28
• 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)