Identity
- Trade Name
- Luminex® 100/200™ FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- The Luminex 100/200 System is a compact analyzer that performs up to 100 bioassays simultaneously, using a single drop of fluid therefore requiring very small patient samples. FDA UDI
- Model / Reference
- Luminex 100/200 FDA UDI
- Description
- The Luminex 100/200 System is a compact analyzer that performs up to 100 bioassays simultaneously, using a single drop of fluid therefore requiring very small patient samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100110 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiplex analyser IVD, laboratory
Luminex® 100/200™ by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2c5e2912-66f0-4c35-b147-c07bc85c0b3e 34 fields · synced Jun 9, 2026