OPTIGEN® AP 3600™ Automated Instrument 95413

GUDID 00813382010204

Automated In Vitro Allergy Diagnostic System

HITACHI CHEMICAL DIAGNOSTICS, INC.

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• Primary Device ID: 00813382010204
• NIH Device Record Key: d60daf39-4097-4f5f-80aa-06c5811136f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIGEN® AP 3600™ Automated Instrument
• Version Model Number: 95413
• Catalog Number: 95413
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813382010204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182793

FDA Product Code

• DHB: System, test, radioallergosorbent (rast) immunological

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: 2019-05-30
• Device Publish Date: 2019-05-22

Devices Manufactured by HITACHI CHEMICAL DIAGNOSTICS, INC.

• 00813382010204 - OPTIGEN® AP 3600™ Automated Instrument: 2019-05-30Automated In Vitro Allergy Diagnostic System
• 00813382010204 - OPTIGEN® AP 3600™ Automated Instrument: 2019-05-30 Automated In Vitro Allergy Diagnostic System
• 00813382010426 - OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND): 2019-05-30 KIT, OPTIGEN US Inhalant 36 (100 ND)
• 00813382010433 - OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND): 2019-05-30 KIT, OPTIGEN US Food 25 (100 ND)
• 00813382010440 - OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND): 2019-05-30 KIT, OPTIGEN US Food 25
• 00813382010006 - OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel: 2018-07-06 KIT, OPTIGEN Universal Panel 20
• 00813382010075 - OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel: 2018-07-06 KIT, OPTIGEN Universal Panel 20
• 00813382010082 - OPTIGEN® Positive Control Reagent: 2018-07-06 OPTIGEN Positive Control
• 00813382010099 - OPTIGEN® Negative Control Reagent: 2018-07-06 OPTIGEN Negative Control