ABX Minotrol 16 5300100303

GUDID 03610230009604

HORIBA ABX SAS

Full blood count IVD, control

• Primary Device ID: 03610230009604
• NIH Device Record Key: 014452c4-1efe-4ec3-ba86-3009ef28319d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX Minotrol 16
• Version Model Number: 5300100303
• Catalog Number: 5300100303
• 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: false
• 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	03610230009604 [Primary]

FDA Product Code

• JPK: Mixture, Hematology Quality Control

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: 2024-10-03
• Device Publish Date: 2024-09-25

On-Brand Devices [ABX Minotrol 16]

• 03610230009604: 5300100303
• 03610230009598: 5300100306
• 03610230009581: 5300100312