ABX PENTRA DX 120

GUDID 03610230006368

ABX PENTRA DX 120 (110V), ABX PENTRA DX 120 (100V)

HORIBA ABX SAS

Haematological cell analyser IVD, automated

• Primary Device ID: 03610230006368
• NIH Device Record Key: fc5e84e1-57b1-473a-9c5c-a6d6d5310f75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA DX 120
• Version Model Number: 1280100120, 1280100121, 1280100122, 1280100124
• 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	03610230006368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050719

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 DX 120]

• 03610230006375: 100 or 110V, ready for SPS
• 03610230006368: ABX PENTRA DX 120 (110V), ABX PENTRA DX 120 (100V)
• 03610230005989: ABX PENTRA DX 120 (110V), ABX PENTRA DX 120 (220V)
• 03610230005972: ABX PENTRA DX 120 (OCCASION)