OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel 85064

GUDID 00813382010389

KIT, OPTIGEN US Food 20

HITACHI CHEMICAL DIAGNOSTICS, INC.

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• Primary Device ID: 00813382010389
• NIH Device Record Key: 0056b86e-2d12-4aa0-a97c-82da182ada84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel
• Version Model Number: 85064
• Catalog Number: 85064
• Company DUNS: 102113867
• Company Name: HITACHI CHEMICAL DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813382010389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051677

FDA Product Code

• PUW: System, test, radioallergosorbent (Rast) immunological, exempt allergens

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: 2017-10-09

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• 00813382010099 - OPTIGEN® Negative Control Reagent: 2018-07-06 OPTIGEN Negative Control