Identity
- Trade Name
- QuickSlide™ FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- HP1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- HP1 FDA UDI
- Primary DI / UDI-DI
- 00816576025039 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
QuickSlide™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI dac8537e-bd78-4fa2-bdbe-42ecf9c0f3ea 36 fields · synced May 30, 2026