Anti-Echinococcus EUROLINE WB (IgG)

GUDID 04049016116110

EUROIMMUN Medizinische Labordiagnostika AG

Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049016116110
• NIH Device Record Key: 110f61a0-a970-4baa-b6ca-dfaa325327ea
• Commercial Distribution Discontinuation: 2026-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Anti-Echinococcus EUROLINE WB (IgG)
• Version Model Number: DY 2321-1601-1 G
• 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
• 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	04049016116110 [Primary]

FDA Product Code

• GPE: Antisera, Positive Control, Echinococcus Spp.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-19
• Device Publish Date: 2022-12-08

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016151814 - ELISA wash buffer 10x conc.: 2026-01-21
• 04049016116110 - Anti-Echinococcus EUROLINE WB (IgG): 2026-01-19
• 04049016116110 - Anti-Echinococcus EUROLINE WB (IgG): 2026-01-19
• 04049016151951 - Tween 20 (IFA): 2026-01-14
• 04049016151968 - Tween 20 (IFA): 2026-01-14
• 04049016092599 - Anti-Glutamate receptor (type NMDA) IFA: 2025-12-29
• 04049016092605 - Anti-Glutamate receptor (type NMDA) IFA: 2025-12-29
• 04049016126034 - EUROArrayScan: 2025-12-29
• 04049016152101 - Reagent tray for incubation of slides: 2025-12-05