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QIAcuityDx® Universal MasterMix Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 260102
by Qiagen, Inc.
Identity
- Trade Name
- QIAcuityDx Universal MasterMix Kit (5mL) EUDAMEDQIAcuityDx® Universal MasterMix Kit FDA UDI
- Generic Name
- Nucleic acid amplification mastermix kit IVD FDA UDI
- Device Name
- QIAcuityDx Universal MasterMix Kit EUDAMEDThe QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures. The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use. The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel. It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies. FDA UDI
- Model / Reference
- 260102 EUDAMED1 FDA UDI
- Description
- The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures. The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use. The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel. It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies. FDA UDI
Identifiers
- Catalog Number
- 260102 FDA UDI
- Primary DI / UDI-DI
- 04053228049432 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228AUMMQCY000000001DS EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid amplification mastermix kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
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
Yes
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
Category: Nucleic acid amplification mastermix kit IVD
QIAcuityDx® Universal MasterMix Kit by Qiagen, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid amplification mastermix kit IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (2)
- FDA UDI 09db09bc-3f19-4b85-b2c3-7a903baf6784 36 fields · synced Jul 23, 2026
- EUDAMED 083e5115-819d-4ed0-bd79-28246da732ca 61 fields · synced Jul 23, 2026