ABX PENTRA HBA1C WB CONTROL

GUDID 03610230005415

HORIBA ABX SAS

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 03610230005415
• NIH Device Record Key: d71e5b77-f3a7-4a80-840e-8ece3596aee8
• Commercial Distribution Discontinuation: 2024-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ABX PENTRA HBA1C WB CONTROL
• Version Model Number: 1220001704
• 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	03610230005415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073309

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2024-07-16
• 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