Identity
- Trade Name
- ASP VIAL FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The ASP VIAL is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP VIAL is used to homogenize and dispense the buffer and patient sample into the Sample Pod prior to loading into the device for deposition on to the slide. FDA UDI
- Model / Reference
- A-03 FDA UDI
- Description
- The ASP VIAL is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP VIAL is used to homogenize and dispense the buffer and patient sample into the Sample Pod prior to loading into the device for deposition on to the slide. FDA UDI
Identifiers
- Catalog Number
- PI-0085469 FDA UDI
- Primary DI / UDI-DI
- 10860008222432 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 Vial 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 b9fcdbdb-ed09-4686-9355-b70e8a18b9b8 36 fields · synced May 29, 2026