ABX PENTRA MULTICAL

GUDID 03610230005125

HORIBA ABX SAS

Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 03610230005125
• NIH Device Record Key: 2cd75376-0153-4908-8097-2366cc4f0f99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA MULTICAL
• Version Model Number: 1220001652
• 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	03610230005125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072115

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-21
• Device Publish Date: 2016-08-16

Devices Manufactured by HORIBA ABX SAS

• 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
• 03610230009581 - ABX Minotrol 16: 2024-10-03
• 03610230009598 - ABX Minotrol 16: 2024-10-03
• 03610230009604 - ABX Minotrol 16: 2024-10-03
• 03610230005545 - ABX PENTRA CK CONTROL: 2024-07-18