Fluoro-CheckTM CRP Test

GUDID 10895160002677

A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases.

NANO-DITECH CORPORATION

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

• Primary Device ID: 10895160002677
• NIH Device Record Key: aeb4f9b0-35a7-4d26-a5c3-4fa01f75d157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluoro-CheckTM CRP Test
• Version Model Number: TF3163
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com
• Phone: 1-609-406-3300
• Email: info@nanoditech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895160002670 [Primary]
GS1	10895160002677 [Unit of Use]

FDA Product Code

• DCN: System, Test, C-Reactive Protein

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-30
• Device Publish Date: 2020-09-22

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