Anti-Candida albicans IFA (IgM)

GUDID 04049016067863

EUROIMMUN Medizinische Labordiagnostika AG

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016067863
• NIH Device Record Key: a9a5d378-146d-40f3-92c4-8cde9859e551
• Commercial Distribution Discontinuation: 2018-09-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Anti-Candida albicans IFA (IgM)
• Version Model Number: FI 2861-1005 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	04049016067863 [Primary]

FDA Product Code

• LSG: Candida Species, Antibody Detection

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: 2016-10-10

On-Brand Devices [Anti-Candida albicans IFA (IgM)]

• 04049016067887: FI 2861-2005 M
• 04049016067870: FI 2861-1010 M
• 04049016067863: FI 2861-1005 M
• 04049016067856: FI 2861-1003 M