POINTE SCIENTIFIC CRP-High Sensitivity C7568-100

GUDID 00811727011039

For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

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

• Primary Device ID: 00811727011039
• NIH Device Record Key: 5ea15227-16fb-4bb1-985e-b02bb3819881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POINTE SCIENTIFIC CRP-High Sensitivity
• Version Model Number: C7568-100
• Catalog Number: C7568-100
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, INC.
• 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: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

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
• 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
• 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	00811727011039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030545

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: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [POINTE SCIENTIFIC CRP-High Sensitivity]

• 00811727011039: For the quantitative determination of C-reactive protein in serum or plasma by latex particle en
• 00811727011022: For the quantitative determination of C-reactive protein in serum or plasma by latex particle en