QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument EUDAMEDQuantStudio™ 7 Pro Dx Real-Time PCR System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories EUDAMED
- Model / Reference
- A50745 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302016148 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302TCF00005354P EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Nucleic acid sample preparation instrument IVD
QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302TCF00005354P | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 0dbe4259-dabd-4fa0-ae05-b64cadf69dab 61 fields · synced Jul 24, 2026
- FDA UDI 312613df-eafe-47f5-ac88-4ba580eb6ef9 32 fields · synced May 30, 2026