Company · US
Life Technologies Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (1 in 12 months)
24recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | 11 |
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 6 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 4 |
| MFD | Cannula, Intrauterine Insemination | 2 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 2 |
| PFF | High Throughput Dna Sequence Analyzer | 2 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 2 |
| GHQ | Stain, Fetal Hemoglobin | 1 |
| N/A | 1 | |
| OOI | Real Time Nucleic Acid Amplification System | 1 |
| PCA | Dna Genetic Analyzer | 1 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 1 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K260827 | Oncomine Dx Express Test Life Technologies Corporation | SBY |
| Jan 8, 2025 | K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel Life Technologies Corporation | QOF |
| Jul 10, 2024 | K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit Life Technologies Corporation | QQX |
| Feb 21, 2020 | K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer Life Technologies Corporation | PCA |
| Jun 22, 2017 | K170299 | Ion PGM Dx System Life Technologies Corporation | PFF |
| Mar 8, 2013 | K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT Life Technologies Corporation | OOI |
| Jun 21, 2012 | K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM Life Technologies, Inc. | NDS |
| Feb 18, 2011 | K103302 | STEMPRO MSC SFM Life Technologies Corporation | NDS |
| May 20, 2010 | K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 Life Technologies Corporation | NDS |
| Feb 16, 2001 | DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) Life Technologies, Inc. | NDS |
| Nov 6, 1995 | K953719 | HUMAN TUBAL FLUID Life Technologies, Inc. | MFD |
| Aug 11, 1995 | K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE Life Technologies, Inc. | MFD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | Life Technologies Corporation 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 Open, Classified |
PFF | None listed |
| Aug 6, 2020 | Life Technologies Corporation The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multipl Terminated |
QJR | None listed |
| Aug 6, 2020 | Life Technologies Corporation The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the Terminated |
QJR | None listed |
| Mar 16, 2020 | Life Technologies Corporation Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens
Catalog Number: A32444 Terminated |
PQP | None listed |
| Mar 16, 2020 | Life Technologies Corporation Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441 Terminated |
PQP | None listed |
| Mar 16, 2020 | Life Technologies Corporation Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443 Terminated |
PQP | None listed |
| Mar 16, 2020 | Life Technologies Corporation 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. Terminated |
PQP | None listed |
| Jun 11, 2019 | Life Technologies Corporation CTSTM Essential 8 Medium Terminated |
N/A | None listed |
| Jun 11, 2019 | Life Technologies Corporation StemPro MSC SFM CTS" Terminated |
NDS | K103302 |
| Aug 24, 2018 | Life Technologies, Corp. Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use
SKU 35050061 Terminated |
KIT | None listed |
| Aug 24, 2018 | Life Technologies, Corp. Gibco Sodium Pyruvate (100 mM)
SKU 11360070, for In-Vitro Diagnostic Use Terminated |
KIT | None listed |
| Aug 24, 2018 | Life Technologies, Corp. Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use
SKU 14040141 Terminated |
KIT | None listed |
| Aug 24, 2018 | Life Technologies, Corp. Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use Terminated |
KIT | None listed |
| Jul 25, 2018 | Life Technologies, Corp. Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium. Terminated |
NDS | None listed |
| Jul 25, 2018 | Life Technologies, Corp. Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. Terminated |
NDS | None listed |
| Jul 25, 2018 | Life Technologies, Corp. Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium. Terminated |
NDS | None listed |
| Jul 25, 2018 | Life Technologies, Corp. Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium. Terminated |
NDS | None listed |
| Jul 25, 2018 | Life Technologies, Corp. GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium. Terminated |
NDS | K022086 |
| Jul 25, 2018 | Life Technologies, Corp. Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium. Terminated |
NDS | K113566 |
| Feb 8, 2018 | Life Technologies Corporation Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441).
A qualitative In Vitro Diagnostic test. Terminated |
PQP | None listed |
| Feb 7, 2018 | Life Technologies Corporation Human Fetal Hemoglobin (HBF-1) FITC Conjugate Terminated |
GHQ | K990641 |
| Dec 4, 2017 | Life Technologies Corporation 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 tes Terminated |
PQP | None listed |
| Aug 26, 2013 | Life Technologies Corporation 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 Terminated |
NYQ | None listed |
| Jan 11, 2012 | Life Technologies Corporation 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 C Terminated |
NYQ | None listed |