Identity
- Trade Name
- Luminex® 100/200™ Calibration Kit FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- xMAP Calibrator Microspheres, Classification (CAL1) and Reporter (CAL2), are polystyrene microspheres that are internally labeled with fluorescent dyes. They serve as system calibrators for Luminex xMAP technology based detectors and are intended to normalize the settings for both the classification channel (CL1, CL2), the doublet discriminator channel (DD), and the reporter channel (RP1). FDA UDI
- Model / Reference
- LX200-CAL-K25 FDA UDI
- Description
- xMAP Calibrator Microspheres, Classification (CAL1) and Reporter (CAL2), are polystyrene microspheres that are internally labeled with fluorescent dyes. They serve as system calibrators for Luminex xMAP technology based detectors and are intended to normalize the settings for both the classification channel (CL1, CL2), the doublet discriminator channel (DD), and the reporter channel (RP1). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100349 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
Luminex® 100/200™ 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
K073506 also covers:
- LIFECODES Fluoroanalyzer — Immucor GTI Diagnostics, Inc.
- Luminex® 100/200™ Performance Verification Kit — Luminex Corporation
- xMAP® Sheath Concentrate PLUS — Luminex Corporation
- xMAP® Sheath Concentrate Pack — Luminex Corporation
- xMAP® Sheath Fluid — Luminex Corporation
- xMAP® Sheath Fluid PLUS — Luminex Corporation
K083846 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 63716e6d-ac8c-4bb8-82f5-28f9e2a4b6f2 36 fields · synced Jun 9, 2026