QuickSlide™ GP3

GUDID 00816576023998

GramPRO 3, Automated Gram Stain Instrument. Intended to be used to perform a Gram stain sequence on slides containing biological specimens in preparation for subsequent microscopic analysis. For in vitro diagnostic use.

HARDY DIAGNOSTICS

Microscope slide stainer IVD

• Primary Device ID: 00816576023998
• NIH Device Record Key: cfe6ae22-e91c-4200-97ec-ded4b9678c44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickSlide™
• Version Model Number: GP3
• Catalog Number: GP3
• 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: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576023998 [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: 2021-11-12
• Device Publish Date: 2021-11-04

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