Identity
- Trade Name
- Globe Scientific FDA UDI
- Generic Name
- Microhaematocrit centrifuge IVD FDA UDI
- Device Name
- Centrifuge, Hematocrit, 24-Place, 230v, 50Hz, EU Plug (includes: 24-Place Hematocrit Rotor Kit with Lid and Reading Disk Lid) FDA UDI
- Model / Reference
- GCH-24-UK FDA UDI
- Description
- Centrifuge, Hematocrit, 24-Place, 230v, 50Hz, EU Plug (includes: 24-Place Hematocrit Rotor Kit with Lid and Reading Disk Lid) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095608442 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
Globe Scientific by Globe Scientific, Llc — 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
- Globe Scientific, Llc
Sources (1)
- FDA UDI a658dbf6-1684-403c-8239-73ae6e32b501 33 fields · synced May 30, 2026