CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 AU-214

GUDID 00817302020946

ALB (Albumin) BCP 3 x 275 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Albumin IVD, reagent

• Primary Device ID: 00817302020946
• NIH Device Record Key: 25fc4cc4-6649-41fb-8869-adb98ee71060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214
• Version Model Number: AU-214
• Catalog Number: AU-214
• 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: 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

Device Dimensions

• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302020946 [Primary]

FDA Product Code

• CJW: BROMCRESOL PURPLE DYE-BINDING, ALBUMIN

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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• 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)