Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal Antibody 3323

GUDID 04053252469404

Enterovirus 71/ Coxsackie A16 Monoclonal Antibody

EMD Millipore Corporation

Enterovirus antigen (serotypes 68-71) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04053252469404
• NIH Device Record Key: 9254ef08-02ad-4b82-b664-7588b8ce2f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal Antibody
• Version Model Number: 3323
• Catalog Number: 3323
• Company DUNS: 829517072
• Company Name: EMD Millipore Corporation
• 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: false
• 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 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com
• Phone: 1 (951) 676-8080
• Email: R128863@merckgroup.com

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
• 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	04053252469404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940473

FDA Product Code

• GOE: Antisera, Fluorescent, Poliovirus 1-3

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: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by EMD Millipore Corporation

• 04053252286612 - Light Diagnostics ™ Pan-Enterovirus Control Slides: 2022-12-13 Pan-Enterovirus Control Slides
• 04053252471827 - Light Diagnostics ™ Pan-Enterovirus Reagent: 2022-12-13 Pan-Enterovirus Reagent
• 04061841171201 - Light Diagnostics ™ Poliovirus Control Slide: 2022-12-13 Poliovirus Control Slide
• 04061841171225 - Light Diagnostics ™ Echovirus Control Slide: 2022-12-13 Echovirus Control Slide
• 04061841171478 - Light Diagnostics ™ Enterovirus70/71 Control Slide: 2022-12-13 Enterovirus70/71 Control Slide
• 04053252270239 - Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent: 2022-12-09 SimulFluor® Flu A / Flu B Reagent
• 04053252282393 - Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides: 2022-12-09 Respiratory Syncytial Virus (RSV) Control Slides
• 04053252286575 - Light Diagnostics ™ Respiratory Viral Control Slides (8 Well): 2022-12-09 Respiratory Viral Control Slides (8 Well)