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| 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
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 |
Trademark Results [QuickSlide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUICKSLIDE 85248401 4026211 Live/Registered |
Stanley Logistics, L.L.C. 2011-02-22 |
 QUICKSLIDE 79162470 4834218 Live/Registered |
Strategy Compass GmbH 2014-11-15 |
 QUICKSLIDE 77116391 3494620 Live/Registered |
TRIPLEX Kunststoffe GmbH 2007-02-26 |
 QUICKSLIDE 74131674 1722910 Live/Registered |
THOMSON INDUSTRIES, INC. 1991-01-22 |
 QUICKSLIDE 73615299 not registered Dead/Abandoned |
ROWI INTERNATIONAL 1986-08-18 |
 QUICKSLIDE 73521645 not registered Dead/Abandoned |
GEIMUPLAST PETER MUNDT GMBH & COMPANY KG 1985-02-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.