The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy

The Hematek slide stainer is a fully automated, bench
Hematek® 3000 System - 10805311

An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KPA

Device Name: Slide Stainer, Automated

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.3800

Third Party Flag: N

Medical Specialty: PA

Device Id: 00630414596563

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A