Identity
- Trade Name
- VERIGENE® II Module FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- The VERIGENE® II Module is a component of the VERGIENE® II System. When installed in the VERIGENE® II System it is capable of automated extraction and purification of nucleic acids from multiple sample types as well as automated amplification, array hybridization, and detection of target nucleic acid sequences. FDA UDI
- Model / Reference
- CN-0425-01 FDA UDI
- Description
- The VERIGENE® II Module is a component of the VERGIENE® II System. When installed in the VERIGENE® II System it is capable of automated extraction and purification of nucleic acids from multiple sample types as well as automated amplification, array hybridization, and detection of target nucleic acid sequences. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487101773 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
Yes
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
VERIGENE® II Module 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 57b23e3d-42df-4f5a-992c-dbd958d4f445 35 fields · synced Jun 9, 2026