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Ion Torrent Dx DNA Quantification Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref A32437 (A32445)
Identity
- Trade Name
- Ion Torrent Dx DNA Quantification Kit EUDAMEDIon Torrent™ Dx DNA Quantification Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Ion Torrent Dx FFPE Sample Preparation Kit EUDAMED
- Model / Reference
- A32437 (A32445) EUDAMEDA32437 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302006309 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302A32445RD EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Netherlands 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
No
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ion Torrent Dx DNA Quantification Kit by Life Technologies Limited — 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 | 0190302A32445RD | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
- EUDAMED SRN
- US-MF-000023929
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 054cd8a9-d0c7-41dc-979f-5d35d0bd2ff8 61 fields · synced Sep 30, 2026
- FDA UDI 9b6fb70b-f85f-41e4-b907-9b2c953d85cf 32 fields · synced May 30, 2026