Identity
- Trade Name
- LW Scientific, Inc. FDA UDI
- Generic Name
- Microhaematocrit centrifuge IVD FDA UDI
- Device Name
- USA E8 Combo, Touch-Screen, Test-Tubes & Crits Carriers, 3500, 90-240v FDA UDI
- Model / Reference
- E8C-U8AT-CRT3 FDA UDI
- Description
- USA E8 Combo, Touch-Screen, Test-Tubes & Crits Carriers, 3500, 90-240v FDA UDI
Identifiers
- Catalog Number
- E8C-U8AT-CRT3 FDA UDI
- Primary DI / UDI-DI
- 00664816005576 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microhaematocrit centrifuge IVD
LW Scientific, Inc. by Lw Scientific, 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
- Lw Scientific, Inc.
Sources (1)
- FDA UDI 6e5afafd-d432-4926-979e-754e4fe53d5d 34 fields · synced May 30, 2026