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QIAcuityDx Nanoplate 26k 24-well
EUDAMEDFDA UDIClass A (EU MDR)
Ref 260001
by QIAGEN GmbH
Identity
- Trade Name
- QIAcuityDx Nanoplate 26k 24-well EUDAMEDQIAcuityDx® Nanoplate 26k 24-well FDA UDI
- Generic Name
- Microplate IVD FDA UDI
- Device Name
- QIAcuityDx Nanoplate 26k 24-well EUDAMEDThe QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic plate-based technology to enable the QIAcuityDx® Four to be used as intended. The QIAcuity® Nanoplate 26k 24-well is used in conjunction with the QIAcuity® Nanoplate Seals, QIAcuity® Nanoplate Tray, and the QIAcuity® Roller to establish a closure to allow air displacement to push samples into the partitioning area of the QIAcuity® Nanoplate 26k 24-well during priming. The QIAcuity® Nanoplate 26k 24-well is intended for in vitro diagnostic use. The QIAcuityDx Nanoplate is not an automated device. FDA UDI
- Model / Reference
- 260001 EUDAMED1 FDA UDI
- Description
- The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic plate-based technology to enable the QIAcuityDx® Four to be used as intended. The QIAcuity® Nanoplate 26k 24-well is used in conjunction with the QIAcuity® Nanoplate Seals, QIAcuity® Nanoplate Tray, and the QIAcuity® Roller to establish a closure to allow air displacement to push samples into the partitioning area of the QIAcuity® Nanoplate 26k 24-well during priming. The QIAcuity® Nanoplate 26k 24-well is intended for in vitro diagnostic use. The QIAcuityDx Nanoplate is not an automated device. FDA UDI
Identifiers
- Catalog Number
- 260001 FDA UDI
- Primary DI / UDI-DI
- 04053228049685 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228ANANQCY000000001LK EUDAMED
- FDA Product Code
- PHG FDA UDI
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Microplate IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QIAcuityDx Nanoplate 26k 24-well by QIAGEN GmbH — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228ANANQCY000000001LK | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (2)
- EUDAMED f6c51c33-b952-41f8-9ffc-4fd03f4c5b32 61 fields · synced Jun 19, 2026
- FDA UDI 53f08fa2-aedd-4767-b4eb-67babbba6e5f 36 fields · synced May 30, 2026