CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049 CC049

GUDID 00817302022100

CRPhsWR (C-Reactive Protein high sensitivity Wide Range) control

CAROLINA LIQUID CHEMISTRIES CORPORATION

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00817302022100
• NIH Device Record Key: a2feada1-e8ac-48f3-9734-d407e374fd47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049
• Version Model Number: CC049
• Catalog Number: CC049
• 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
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
• Special Storage Condition, Specify: Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302022100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002651

FDA Product Code

• DCK: C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND 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: 2018-12-17
• Device Publish Date: 2016-09-01

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