Identity
- Trade Name
- ASP HOOD FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The ASP HOOD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP HOOD protects the user from exposure to potentially hazardous material and prevents possible sample cross contamination by sealing and containing the staining reagents and sample during device operation. FDA UDI
- Model / Reference
- A-03 FDA UDI
- Description
- The ASP HOOD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP HOOD protects the user from exposure to potentially hazardous material and prevents possible sample cross contamination by sealing and containing the staining reagents and sample during device operation. FDA UDI
Identifiers
- Catalog Number
- PI-0077054 FDA UDI
- Primary DI / UDI-DI
- 10860008222425 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microscope slide stainer IVD
Asp Hood by ASP Health Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- ASP Health Inc.
Sources (1)
- FDA UDI 03fbbd83-2ef0-40be-add8-d8a7531de1d2 36 fields · synced Jun 6, 2026