Light Diagnostics™ CMV IFA Kit 3135

GUDID 04053252676024

CMV IFA Kit

EMD Millipore Corporation

Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 04053252676024
• NIH Device Record Key: db6500f6-60cf-423e-a4ea-445b4375f732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics™ CMV IFA Kit
• Version Model Number: 3135
• Catalog Number: 3135
• 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: 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: false
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053252676024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935809

FDA Product Code

• GQH: Antigen, Cf (Including Cf Control), Cytomegalovirus

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: 2016-09-26

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)