Anti-RSV IFA (IgM)

GUDID 04049016059288

EUROIMMUN Medizinische Labordiagnostika AG

Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016059288
• NIH Device Record Key: fde8998e-0fb4-47ad-a564-4134debac7e8
• Commercial Distribution Discontinuation: 2018-09-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Anti-RSV IFA (IgM)
• Version Model Number: FI 2670-1010 M
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016059288 [Primary]

FDA Product Code

• LKT: Respiratory Syncytial Virus, Antigen, Antibody, Ifa

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: 2018-09-14
• Device Publish Date: 2016-09-24

On-Brand Devices [Anti-RSV IFA (IgM)]

• 04049016059295: FI 2670-2005 M
• 04049016059288: FI 2670-1010 M
• 04049016059271: FI 2670-1005 M
• 04049016059264: FI 2670-1003 M