Lumipulse SARS-CoV-2 Ag Controls

GUDID 04987270231876

FUJIREBIO INC.

SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control

• Primary Device ID: 04987270231876
• NIH Device Record Key: 3ede44b5-9026-4e1f-8419-a7f7d31ee003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse SARS-CoV-2 Ag Controls
• Version Model Number: 231876
• Company DUNS: 710873907
• Company Name: FUJIREBIO 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com

Device Dimensions

• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270231876 [Primary]

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: 2022-03-22
• Device Publish Date: 2022-03-14

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