ABX PENTRA 60C+

GUDID 03610230006009

HORIBA ABX SAS

Haematological cell analyser IVD, automated

• Primary Device ID: 03610230006009
• NIH Device Record Key: c9fc9cce-ea25-4500-94b2-2e7d15235b3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA 60C+
• Version Model Number: 1280120006, 1280120008
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	03610230006009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030144

FDA Product Code

• GKZ: Counter, Differential Cell

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: 2019-12-23
• Device Publish Date: 2016-09-02

On-Brand Devices [ABX PENTRA 60C+]

• 03610230006429: ABX PENTRA 60C+ (110V)
• 03610230006009: 1280120006, 1280120008