QuickSlide™ HP1

GUDID 00816576025039

HemaPRO Automated Hematology Stain Instrument. Intended to be used to automatically perform a hematology stain (Wright’s-Giemsa) sequence on a slide containing a biological specimen for in vitro diagnostic use.

HARDY DIAGNOSTICS

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD

• Primary Device ID: 00816576025039
• NIH Device Record Key: dac8537e-bd78-4fa2-bdbe-42ecf9c0f3ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickSlide™
• Version Model Number: HP1
• Catalog Number: HP1
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com
• Phone: 800-266-2222
• Email: TechnicalServices@HardyDiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576025039 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [QuickSlide™]

• 00816576023998: GramPRO 3, Automated Gram Stain Instrument. Intended to be used to perform a Gram stain sequence
• 00816576025039: HemaPRO Automated Hematology Stain Instrument. Intended to be used to automatically perform a he