ABX PENTRA 60

GUDID 03610230006412

ABX PENTRA 60 (110V)

HORIBA ABX SAS

Haematological cell analyser IVD, automated

• Primary Device ID: 03610230006412
• NIH Device Record Key: 61ddb25f-5459-434c-9a2e-184effc148c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA 60
• Version Model Number: 1280120064, 1280120066
• 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	03610230006412 [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 60]

• 03610230006412: ABX PENTRA 60 (110V)
• 03610230006016: ABX PENTRA 60 (110V)