Identity
- Trade Name
- Luminex® 100/200™ Performance Verification Kit FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- xMAP Control Microspheres, Classification (CON1) and Reporter (CON2), are polystyrene microspheres that are internally labeled with fluorescent dyes. The control microspheres are intended to verify the calibration and optical integrity for the Luminex 100/200 System. Classification Control Microspheres verify both classification channels and the doublet discriminator channel (DD). Reporter Control Microspheres verify the reporter channel. FDA UDI
- Model / Reference
- LX200-CON-K25 FDA UDI
- Description
- xMAP Control Microspheres, Classification (CON1) and Reporter (CON2), are polystyrene microspheres that are internally labeled with fluorescent dyes. The control microspheres are intended to verify the calibration and optical integrity for the Luminex 100/200 System. Classification Control Microspheres verify both classification channels and the doublet discriminator channel (DD). Reporter Control Microspheres verify the reporter channel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100332 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™ Performance Verification Kit by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiplex analyser IVD, laboratory.
- MEDTOXScan® Reader — MEDTOX DIAGNOSTICS, INC. · Class I
- LIFECODES Fluoroanalyzer — Immucor GTI Diagnostics, Inc. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K073506 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI fd06d5df-960b-4183-bdf1-080a11f9f72f 36 fields · synced Jun 9, 2026