Data / Medical devices / Singapore / Life Technologies Holdings Pte Ltd.
Life Technologies Holdings Pte Ltd.: FDA-registered device maker in SINGAPORE North West, Singapore, 2 510(k) clearances
Life Technologies Holdings Pte Ltd. is registered with the FDA (registration 3003673482) in SINGAPORE North West, Singapore. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 8, 2013. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003673482
- Address
- BLK 33, MARSILING INDUSTRIAL ESTATE ROAD 3, No. 07-06, SINGAPORE North West, Singapore, 739256
- Owner or operator
- Life Technologies Corporation (9915045)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 30, 2009
- Registered through
- 2026
- Brand names listed
- 3500 Dx Capillary Array 50 cm, 3500 Dx Capillary Array 50-cm, 3500 Dx Genetic Analyzer, 3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set, 3500 Dx Series 96-Well Standard Retainer & Base Set, 3500 Dx Series Data Collection Software 3 IVD v3.2, 3500 Dx Series Polymer Pouch Caps, 3500 Dx Series Septa 96-Well and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dna Genetic Analyzer | PCA | 2 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| High Throughput Dna Sequence Analyzer | PFF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer | accessdata.fda.gov |
| Reagents For Molecular Diagnostic Test Systems | PFT | 1 | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Thermocycler, Generic | OUL | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 8, 2013 | K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | OOI | Substantially Equivalent | Life Technologies Corporation | accessdata.fda.gov |
| September 30, 2008 | K082562 | APPLIED BIOSYSTEMS 7500 FAST DX | NSU | Substantially Equivalent | Applied Biosystems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 14, 2026 | 99885 | Class II | Ongoing | Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer | DNA or RNA sequencing system software has vulnerabilities. | accessdata.fda.gov |
| September 26, 2019 | 83786 | Class II | Terminated | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9 | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant | accessdata.fda.gov |
Compare with other makers
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Instrumentation For Clinical Multiplex Test Systems
- All makers of High Throughput Dna Sequence Analyzer
- All makers of Thermocycler, Generic
- All makers of Reagents For Molecular Diagnostic Test Systems
- All makers of Clinical Sample Concentrator
Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.