Identity
- Trade Name
- X-CAL Calibrator FDA UDI
- Generic Name
- Full blood count IVD, calibrator FDA UDI
- Device Name
- X-Cal FSR Kit (5X4.6ML) FDA UDI
- Model / Reference
- 110-4008-0 FDA UDI
- Description
- X-Cal FSR Kit (5X4.6ML) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14987562460592 FDA UDI
- 510(k) Number
- K083200 FDA UDI
- FDA Product Code
- KRX FDA UDI
- GMDN Term
- Full blood count IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8150 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
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 — 4.6 Milliliter FDA UDI
Category: Full blood count IVD, calibrator
X-CAL Calibrator by Sysmex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083200 also covers:
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 3c6246ac-4b6b-41bc-a503-013536c79f7e 37 fields · synced May 30, 2026