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Ion Torrent Dx Sample Dilution Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref A32439 (A32445)
Identity
- Trade Name
- Ion Torrent Dx Sample Dilution Kit EUDAMEDIon Torrent™Dx Sample Dilution Kit FDA UDI
- Generic Name
- Buffered sample diluent IVD, manual FDA UDI
- Device Name
- Ion Torrent Dx FFPE Sample Preparation Kit EUDAMED
- Model / Reference
- A32439 (A32445) EUDAMEDA32439 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302006323 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
- Buffered sample diluent IVD, manual 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 Sample Dilution 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 a52156b8-4d5d-4f0d-a994-1d7817b9ffde 61 fields · synced Jul 25, 2026
- FDA UDI 1a663b52-bef5-4300-a441-100998698402 32 fields · synced May 30, 2026