Data / Medical devices / United States / Life Technologies Corporation
Life Technologies Corporation: FDA-registered device maker in Frederick, MD, United States, 2 PMA approvals
Life Technologies Corporation is registered with the FDA (registration 3003335080) in Frederick, MD, United States. It lists 11 device types. The FDA files 2 PMA approvals under its listings, the newest dated July 2, 2025. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003335080
- Address
- 7335 Executive Way, Frederick, MD, United States, 21704
- Owner or operator
- Life Technologies Corporation (9915045)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- March 3, 2004
- Registered through
- 2026
- Brand names listed
- 10% Normal Goat Serum, 3500 Dx Capillary Array 50-cm, 3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set, 3500 Dx Series 96-Well Standard Retainer & Base Set, 3500xL Dx Capillary Array 50-cm, 96-Well Septa Dx, A50847 Ion 530 Chip Kit, A51869 Ion 520 Chip Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antiserum, Cf, Q Fever | GPR | 1 | Manufacturer for export | accessdata.fda.gov |
| Clinical Sample Concentrator | JJH | 1 | Manufacturer | accessdata.fda.gov |
| Fixative, Formalin-Containing | LDY | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| High Throughput Dna Sequence Analyzer | PFF | 2 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Reagents And Kits | NJT | 1 | Manufacturer | accessdata.fda.gov |
| Next Generation Sequencing Based Tumor Profiling Test | PZM | 2 | Manufacturer for export | accessdata.fda.gov |
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Manufacturer | accessdata.fda.gov |
| Reagents For Molecular Diagnostic Test Systems | PFT | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | N | Contract manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 2, 2025 | P240040 | Oncomine Dx Express Test | PQP | 5 | September 9, 2026 | accessdata.fda.gov |
| June 22, 2017 | P160045 | Oncomine Dx Target Test | PQP | 44 | March 4, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 7, 2024 | 94122 | Class II | Ongoing | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracte | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument | accessdata.fda.gov |
| March 16, 2020 | 85203 | Class II | Terminated | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442. | Extended Expiration Date prior to clearance | accessdata.fda.gov |
| February 8, 2018 | 79649 | Class II | Terminated | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test. | The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen. | accessdata.fda.gov |
| February 7, 2018 | 79603 | Class II | Terminated | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives) | accessdata.fda.gov |
| December 4, 2017 | 79437 | Class II | Terminated | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted h | The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens. | accessdata.fda.gov |
| May 13, 2013 | 65770 | Class II | Terminated | HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests. | Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. | accessdata.fda.gov |
| November 14, 2011 | 60542 | Not yet classified | Terminated | SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to | In vitro diagnostic reagent may be contaminated with a fungal contaminant. | accessdata.fda.gov |
Compare with other makers
- All makers of Antiserum, Cf, Q Fever
- All makers of Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- All makers of High Throughput Dna Sequence Analyzer
- All makers of Reagents For Molecular Diagnostic Test Systems
- All makers of Reagents, 2019-Novel Coronavirus Nucleic Acid
- All makers of Immunohistochemistry Reagents And Kits
Updated September 9, 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.