Yumizen C1200 Pyridoxal-5-Phosphate

GUDID 03610230008041

HORIBA ABX SAS

Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control Complement factor H IVD, control

• Primary Device ID: 03610230008041
• NIH Device Record Key: 33cf3ac5-0e9e-4a79-bacc-46e0f5418212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 Pyridoxal-5-Phosphate
• Version Model Number: 1300023963
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• 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: 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	03610230008041 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2020-09-08
• Device Publish Date: 2020-08-31

Devices Manufactured by HORIBA ABX SAS

• 03610230004890 - ABX PENTRA ALP CP: 2023-07-06
• 03610230004913 - ABX PENTRA AMYLASE CP: 2023-07-06
• 03610230004920 - ABX PENTRA AST CP: 2023-07-06
• 03610230004937 - ABX PENTRA GGT CP: 2023-07-06
• 03610230004944 - ABX PENTRA LIPASE CP: 2023-07-06
• 03610230004975 - ABX PENTRA CHOLESTEROL CP: 2023-07-06
• 03610230004982 - ABX PENTRA BILIRUBIN, DIRECT CP: 2023-07-06
• 03610230004999 - ABX PENTRA HDL DIRECT CP: 2023-07-06