Yumizen C1200 Direct Bilirubin

GUDID 03610230006870

HORIBA ABX SAS

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 03610230006870
• NIH Device Record Key: 9799cf97-032c-43d5-8203-26ecf11f73cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 Direct Bilirubin
• Version Model Number: 1300023834
• 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	03610230006870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060325

FDA Product Code

• CIG: Diazo Colorimetry, Bilirubin

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: 2020-09-07
• Device Publish Date: 2020-08-28

Devices Manufactured by HORIBA ABX SAS

• 03610230005545 - ABX PENTRA CK CONTROL: 2024-07-18
• 03610230005392 - ABX PENTRA HBA1C WB: 2024-07-16
• 03610230005408 - ABX PENTRA HBA1C WB CAL: 2024-07-16
• 03610230005415 - ABX PENTRA HBA1C WB CONTROL: 2024-07-16
• 03610230005460 - ABX PENTRA HBA1C WB HEMOLYSIS REAGENT: 2024-07-16
• 03610230008157 - NUCEDIFF (1L): 2024-06-07
• 03610230008508 - Yumizen SPS: 2024-06-07
• 03610230008928 - Yumizen T6000: 2024-06-07 Right module SPS only