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

• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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
• 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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