FDA Registration
Active
🇺🇸 United States
LIFE TECHNOLOGIES CORPORATION
Reg #: 3011104381
·
FEI: 3011104381
·
Expires 2026
Products
5
Proprietary Names
63
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- LIFE TECHNOLOGIES CORPORATION
- Registration Number
- 3011104381
- FEI Number
- 3011104381
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 180 Oyster Point Blvd
- City
- S San Fran
- State
- CA
- ZIP
- 94080
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241806
- PMA Number
- P240040
Owner / Operator
- Firm Name
- Life Technologies Corporation
- Operator Number
- 9915045
- Address
- 5781 Van Allen Way, --
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2025-01-31 |
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | Class 3 | Unknown | No | 2025-07-08 |
| High Throughput Dna Sequence Analyzer | PFF | Class 2 | Immunology | No | 2014-09-17 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-03-30 |
| Dna Genetic Analyzer | PCA | Class 2 | Clinical Chemistry | No | 2013-03-13 |
Proprietary Names
Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel
Oncomine Dx Express Test DNA Control
Oncomine Dx Express Test ADF-FFPE
Oncomine Dx Express Test NTC Control
Oncomine Dx Express Test RNA Control
Oncomine Dx Express Test Panel
Genexus Dx SW 6.8.2.1
Ion One Touch ES Dx
Ion One Touch Dx
Ion PGM Dx Chip Minifuge
Torrent Suite Dx SW
Personal Genome Machine Dx (PGM) Dx
Torrent Suite DX SW, Installer v5.12.5
Sentosa® SQ Suite Software
Genexus Dx Cartridge
Genexus Dx Bottle 1 and 3
Torrent Suite DX SW, Installer V5.14.2
Torrent Suite Dx SW v5.6.4
Genexus Dx Pipette Tips
Genexus Dx Conical Bottles
Genexus Dx Barcodes 1-32 HD
Genexus Dx Strip 2-HD
Genexus Dx Filter
Genexus Dx Strip 4
Genexus Dx SW 6.8.2
Torrent Suite DX SW, Installer V5.14
Torrent Suite Dx SW v5.8 Installer
Genexus Dx Strip 1
Genexus Dx Bottle 2
Genexus Dx Strip 3-GX5
Genexus Dx Integrated Sequencer
Genexus Dx GX5 Chip and Genexus Coupler
TaqPath COVID-19, FluA, FluB Combo Kit
TaqPath COVID-19 Combo Kit
TaqPath COVID-19 High Throughput Combo Kit
TaqPath COVID-19 Fast PCR Combo Kit 2
TaqPath COVID-19 RNase P Combo Kit 2
SeqStudio 8 Flex Dx Genetic Analyzer
3500 Dx Series 96-Well Standard Retainer & Base Set
Hi-Di Formamide 3500 Dx Series
POP-6 (384) Performance Optimized Polymer 3500 Dx Series
3500 Dx Series Septa 96-Well
POP-7 (384) Performance Optimized Polymer 3500 Dx Series
3500xL Dx Capillary Array 50 cm
Conditioning Reagent 3500 Dx Series
3500 Dx Series Data Collection Software 3 IVD v3.2
3500xL Dx Genetic Analyzer
3500 Dx Series Septa Cathode Buffer Container
POP-6 (960) Performance Optimized Polymer 3500 Dx Series
3500 Dx Genetic Analyzer
Sequencing Standard v1.1 3500 Dx Series
3500 Dx Series Polymer Pouch Caps
GeneScan 600 LIZ Size Standard v2 - Dx
3500 Dx Capillary Array 50 cm
Anode Buffer Container 3500 Dx Series
3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set
DS-30 Matrix Standard Kit (Dye Set D) - Dx
Pump Cleaning Kit 3500 Dx Series
DS-33 Matrix Standard (Dye Set G5) - Dx
Cathode Buffer Container 3500 Dx Series
POP-7 (960) Performance Optimized Polymer 3500 Dx Series
Sequencing Standard BigDyeTM Terminator V1.1-Dx
SeqStudio 24 Flex Dx Genetic Analyzer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility