Life Technologies Holdings Pte Ltd.
SINGAPORE North West, SG
LIFE TECHNOLOGIES HOLDINGS PTE LTD appears in FDA device records in SINGAPORE North West, SG. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010286073 | 3010286073 | LIFE TECHNOLOGIES HOLDINGS PTE LTD | 7 Gul Circle, #2M-01/08, Jurong West North West 629563 SG | 2026 | |
| 3003673482 | 3003673482 | Life Technologies Holdings Pte Ltd. | BLK 33, MARSILING INDUSTRIAL, SINGAPORE North West 739256 SG | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJHClinical Sample Concentrator
- PCADna Genetic Analyzer
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PFFHigh Throughput Dna Sequence Analyzer
- NSUInstrumentation For Clinical Multiplex Test Systems
- PFTReagents For Molecular Diagnostic Test Systems
- OOIReal Time Nucleic Acid Amplification System
- PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
- OULThermocycler, Generic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0188-2020 | Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601 | 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 | Class II | Terminated | |
| Z-0187-2020 | Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178 | 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 | Class II | Terminated | |
| Z-0186-2020 | Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15 | 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 | Class II | Terminated | |
| Z-0185-2020 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain