Identity
- Trade Name
- MAGPIX® Calibration Kit FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MAGPIX instrument. During calibration, the system adjusts LED current and calibration factors for CL1, CL2, and RP1 until those values match the imported target values, thus calibrating the classification map. FDA UDI
- Model / Reference
- MPXIVD-CAL-K25 FDA UDI
- Description
- The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MAGPIX instrument. During calibration, the system adjusts LED current and calibration factors for CL1, CL2, and RP1 until those values match the imported target values, thus calibrating the classification map. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100271 FDA UDI
- 510(k) Number
- K121894 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Multiplex analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
No
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
Category: Multiplex analyser IVD, laboratory
MAGPIX® Calibration Kit by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121894 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
- Luminex Corporation
Sources (1)
- FDA UDI 812a91d2-993b-4d07-9a13-b476e5b0c7cd 36 fields · synced Jun 9, 2026