Light Diagnostics™ Rabies DFA Reagent 5100

GUDID 04053252739408

Rabies DFA Reagent

EMD Millipore Corporation

Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody

• Primary Device ID: 04053252739408
• NIH Device Record Key: 94f7e3b3-c62b-442d-9cf7-811fd2bcf634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics™ Rabies DFA Reagent
• Version Model Number: 5100
• Catalog Number: 5100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053252739408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972975

FDA Product Code

• GOI: Antiserum, Fluorescent, Rabies Virus

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: 2016-09-23

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)