Dako

GUDID 05700571104057

c-Kit pharmDx for Autostainer

Dako North America, Inc.

CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05700571104057
• NIH Device Record Key: b3085337-af37-4adc-95ce-74ce743d79e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dako
• Version Model Number: K1907
• Company DUNS: 099999732
• Company Name: Dako North America, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• 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	05700571104057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040011

FDA Product Code

• NKF: Immunohistochemistry Antibody Assay, C-Kit

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: 2016-10-21

On-Brand Devices [Dako]

• 05700571104057: c-Kit pharmDx for Autostainer
• 05700571104040: c-Kit pharmDx
• 05700571102244: Monoclonal Mouse Anti-Human Wilms' Tumor 1 (WT1) Protein Clone 6F-H2
• 05700571105603: DuoFLEX Cocktail Anti-AMACR Anti-Cytokeratin HMW Anti-Cytokeratin 5/6 Ready-to-Use (Link)
• 05700571105597: DuoFLEX Cocktail Anti-CD3 Anti-CD20cy Ready-to-Use (Link)
• 05700571105580: DuoFLEX Cocktail Anti-S100 Anti-Tyrosinase Anti-Melan-A Ready-to-Use (Link)
• 05700571101520: Polyclonal Rabbit Anti-Somatostatin
• 05700571101391: FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15 Clone 23A3 Ready-to-Use
• 05700571101377: FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker Clone SPM314 Ready-to-Use (Dako Au
• 05700571101360: FLEX Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5 Ready-to-Use (Dako Autostainer/ Auto