CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214 CC214

GUDID 00817302020229

ALB (Albumin) BCP 2 x 300 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Albumin IVD, reagent

• Primary Device ID: 00817302020229
• NIH Device Record Key: eee1f992-4697-4824-ab41-c92bbe3ba8cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214
• Version Model Number: CC214
• Catalog Number: CC214
• 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
• 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
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com
• Phone: +1(800)471-7272
• Email: ContactSales@CarolinaChemistries.com

Device Dimensions

• Total Volume: 101 Milliliter
• Total Volume: 101 Milliliter
• Total Volume: 101 Milliliter
• Total Volume: 101 Milliliter
• Total Volume: 101 Milliliter
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter
• Device Size Text, specify: 0
• Total Volume: 101 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Special Storage Condition, Specify: Between 0 and 0 *After opening, the reagent is stable for 30 days on board a clinical analyzer
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302020229 [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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