OPTIGEN® Negative Control Reagent 82062

GUDID 00813382010099

OPTIGEN Negative Control

HITACHI CHEMICAL DIAGNOSTICS, INC.

Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, control

• Primary Device ID: 00813382010099
• NIH Device Record Key: f00fe926-c0e8-4b3a-a211-d7e7ff11592f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIGEN® Negative Control Reagent
• Version Model Number: 82062
• Catalog Number: 82062
• Company DUNS: 102113867
• Company Name: HITACHI CHEMICAL DIAGNOSTICS, INC.
• Device Count: 3
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813382010099 [Primary]
GS1	00813382010310 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051677

FDA Product Code

• DGC: IGE, ANTIGEN, ANTISERUM, 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: 2016-08-19

Devices Manufactured by HITACHI CHEMICAL DIAGNOSTICS, INC.

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