Yumizen C1200 Immunoglobulin M

GUDID 03610230007365

HORIBA ABX SAS

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 03610230007365
• NIH Device Record Key: 44a37c3a-091a-4fa4-9cdb-fd195bde469c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 Immunoglobulin M
• Version Model Number: 1300023884
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610230007365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193525

FDA Product Code

• DFT: Igm, Antigen, Antiserum, Control

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: 2020-07-21
• Device Publish Date: 2020-07-13

Devices Manufactured by HORIBA ABX SAS

• 03610230005774 - ABX PENTRA MICRO-ALB CAL: 2025-08-18
• 03610230005781 - ABX PENTRA MICRO ALB CONTROL L/H: 2025-08-18
• 03610230008232 - ABX Pentra Micro ALB 2 Cal: 2025-08-18
• 03610230008966 - Yumizen P8000: 2025-07-15 1 connexion
• 03610230009444 - Yumizen H2500: 2024-12-09
• 03610230009451 - Yumizen H2500: 2024-12-09
• 03610230009611 - ABX Minocal: 2024-10-07
• 03610230008584 - BFTROL: 2024-10-04 BF Hematology control