Identity
- Trade Name
- RANGE CHECK X lll FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- Range Check X lll 24X3.0ML WBC/RBC/PLT FDA UDI
- Model / Reference
- 218981 FDA UDI
- Description
- Range Check X lll 24X3.0ML WBC/RBC/PLT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14987562460387 FDA UDI
- 510(k) Number
- K960557 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
RANGE CHECK X lll by Sysmex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Sysmex Corp.
Sources (1)
- FDA UDI 22439a48-2aff-4ab3-85f0-0ee55505f5de 38 fields · synced May 30, 2026