ABX SPS EVOLUTION

GUDID 03610230006481

HORIBA ABX SAS

Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD Microscope slide maker/stainer IVD

• Primary Device ID: 03610230006481
• NIH Device Record Key: c390aab9-b4ce-47a6-a1c4-e278e182dafd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX SPS EVOLUTION
• Version Model Number: 1280160018, 1280160020
• 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	03610230006481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050719

FDA Product Code

• KPA: Slide Stainer, Automated

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: 2022-09-16
• Device Publish Date: 2016-09-02

On-Brand Devices [ABX SPS EVOLUTION]

• 03610230006498: 1280160014, 1280160016
• 03610230006481: 1280160018, 1280160020