FDA UDI
In Commercial Distribution
🇺🇸 United States
Ion Torrent™ Genexus™ Dx Purification instrument
DI: 10190302017800
·
Model: A53257
·
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ion Torrent™ Genexus™ Dx Purification instrument
- Primary DI
- 10190302017800
- Version / Model
- A53257
- Company Name
- LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- Labeler DUNS
- 628548377
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-13
- Public Version
- 1
- Public Version Date
- 2025-10-21
- Public Version Status
- New
- Public Device Record Key
- 0e94614b-55d6-4a76-ab87-4b35c8dd8da2
Device Description
The Genexus Dx Purification Instrument is an automated magnetic particle-based system with liquid transfer capabilities that can purify nucleic acids from FFPE and plasma samples, with an integrated quantitation system to provide concentrations of the eluted nucleic acids.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48031 | Thermal cycler nucleic acid amplification analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302017800 | GS1 |