Identity
- Trade Name
- UNICO POWERSPIN BX FDA UDI
- Generic Name
- Microhaematocrit centrifuge IVD FDA UDI
- Device Name
- POWERSPIN™ BX CENTRIFUGE, VARIABLE SPEED 1,000-13,000 RPM WITH 8 PLACE TUBE ROTOR, 24 PLACE MICROHEMATOCRIT ROTOR AND 24 PLACE MICROCENTRIFUGE ROTOR, 110 V FDA UDI
- Model / Reference
- C885 FDA UDI
- Description
- POWERSPIN™ BX CENTRIFUGE, VARIABLE SPEED 1,000-13,000 RPM WITH 8 PLACE TUBE ROTOR, 24 PLACE MICROHEMATOCRIT ROTOR AND 24 PLACE MICROCENTRIFUGE ROTOR, 110 V FDA UDI
Identifiers
- Catalog Number
- C885 FDA UDI
- Primary DI / UDI-DI
- 00816668020096 FDA UDI
- FDA Product Code
- GKG FDA UDI
- GMDN Term
- Microhaematocrit centrifuge IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6400 FDA UDI
- Commercial Distribution
- 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
Category: Microhaematocrit centrifuge IVD
Unico Powerspin Bx by United Products & Instruments, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- United Products & Instruments, Inc.
Sources (1)
- FDA UDI d8aef4af-388c-4d18-9bfa-557ad6145ac3 35 fields · synced May 30, 2026