Light Diagnostics ™ Coxsackievirus B1 Monoclonal Antibody 3304

GUDID 04053252326264

Coxsackievirus B1 Monoclonal Antibody

EMD Millipore Corporation

Coxsackie A/B virus antigen IVD, reagent

• Primary Device ID: 04053252326264
• NIH Device Record Key: 15319bb2-3074-4fcf-8db1-1d595e799413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics ™ Coxsackievirus B1 Monoclonal Antibody
• Version Model Number: 3304
• Catalog Number: 3304
• 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	04053252326264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936145

FDA Product Code

• GNM: Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

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

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• 04053252282393 - Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides: 2022-12-09 Respiratory Syncytial Virus (RSV) Control Slides
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