Identity
- Trade Name
- LW Scientific FDA UDI
- Generic Name
- White blood cell differential count recorder IVD, non-powered FDA UDI
- Device Name
- Differential Counter, 8 key, manual FDA UDI
- Model / Reference
- CTL-DIFM-08KY FDA UDI
- Description
- Differential Counter, 8 key, manual FDA UDI
Identifiers
- Catalog Number
- CTL-DIFM-08KY FDA UDI
- Primary DI / UDI-DI
- 00664816001134 FDA UDI
- FDA Product Code
- GLG FDA UDI
- GMDN Term
- White blood cell differential count recorder IVD, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6160 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
Yes
FDA UDI
Category: White blood cell differential count recorder IVD, non-powered
LW Scientific by Lw Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as White blood cell differential count recorder IVD, non-powered.
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- LW Scientific — LW SCIENTIFIC, INC. · Class I
- 8-key Manual Differential Counter — LW SCIENTIFIC, INC. · Class I
- 5-key Manual Differential Counter — LW SCIENTIFIC, INC. · Class I
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
- Lw Scientific, Inc.
Sources (1)
- FDA UDI dd005d2a-058f-4edd-808c-1ba9200fc67e 34 fields · synced May 30, 2026