Identity
- Trade Name
- Ion Torrent FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, control FDA UDI
- Model / Reference
- A29362 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302005852 FDA UDI
- PMA Number
- P160045 FDA UDI
- FDA Product Code
- PQP FDA UDI
- GMDN Term
- Nucleic acid hybridization detection IVD, control FDA UDI
Classification
- Device Class
- Class III 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
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
No
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 hybridization detection IVD, control
Ion Torrent by Life Technologies Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P160045 also covers:
- Ion Torrent — LIFE TECHNOLOGIES LIMITED
- Ion Torrent — LIFE TECHNOLOGIES LIMITED
- Oncomine™ Dx Target DNA Control Kit — LIFE TECHNOLOGIES LIMITED
- Oncomine™ Dx Target Test User Guide and Assay Definition File — LIFE TECHNOLOGIES LIMITED
- Oncomine™ Dx Target Test User Guides and Assay Definition File — LIFE TECHNOLOGIES LIMITED
- Oncomine™ Dx Target Test User Guides and Assay Definition File — LIFE TECHNOLOGIES LIMITED
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 III | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Limited
Sources (1)
- FDA UDI 8271253e-929b-402d-b704-0ede524247a6 33 fields · synced Jun 8, 2026