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QIAcuityDx® Universal MasterMix Kit
FDA UDIClass I (US FDA UDI)
by Qiagen, Inc.
Identity
- Trade Name
- QIAcuityDx® Universal MasterMix Kit FDA UDI
- Generic Name
- Nucleic acid amplification mastermix kit IVD FDA UDI
- Device Name
- 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
- Model / Reference
- 1 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
- 260101 FDA UDI
- Primary DI / UDI-DI
- 04053228049418 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Nucleic acid amplification mastermix kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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 — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 8f1a3253-a2e2-4d43-bde8-afa960c95d66 36 fields · synced May 30, 2026