Light Diagnostics CMV DFA Reagent 5090

GUDID 04053252282089

Light Diagnostics CMV DFA Reagent

EMD Millipore Corporation

Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 04053252282089
• NIH Device Record Key: 09ed0f70-2e4d-4107-ba5e-43c036f29bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics CMV DFA Reagent
• Version Model Number: 5090
• Catalog Number: 5090
• 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

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	04053252282089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951821

FDA Product Code

• LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus

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: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [Light Diagnostics CMV DFA Reagent]

• 04053252282089: Light Diagnostics CMV DFA Reagent
• 04053252507397: Light Diagnostics CMV DFA Reagent