Yumizen C1200 LDL Cal

GUDID 03610230009314

HORIBA ABX SAS

Low density lipoprotein (LDL) cholesterol IVD, calibrator Low density lipoprotein (LDL) cholesterol IVD, calibrator Low density lipoprotein (LDL) cholesterol IVD, calibrator Low density lipoprotein (LDL) cholesterol IVD, calibrator

• Primary Device ID: 03610230009314
• NIH Device Record Key: 2d8c911a-2db2-47e8-ad1b-bf571a9159e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 LDL Cal
• Version Model Number: 1300076291
• 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	03610230009314 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2020-11-10
• Device Publish Date: 2020-11-02

Devices Manufactured by HORIBA ABX SAS

• 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
• 03610230008935 - Yumizen T6000: 2024-06-07 Right module Inst only