Product code PQP ยท Class 3
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
0510(k)s in 12 months (0 all time)
5recalls in 12 months (18 all time)
0recalls that name a 510(k)
Top companies in PQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Foundation Medicine, Inc. | 0 | 10 |
| Life Technologies Corporation | 0 | 6 |
| AGILENT TECHNOLOGIES INC./US | 0 | 1 |
| CARIS LIFE SCIENCES | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Foundation Medicine, Inc. Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. Open, Classified |
PQP | None listed |
| Apr 23, 2026 | Foundation Medicine, Inc. Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990 Open, Classified |
PQP | None listed |
| Apr 22, 2026 | Foundation Medicine, Inc. Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Open, Classified |
PQP | None listed |
| Nov 21, 2025 | Foundation Medicine, Inc. FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Open, Classified |
PQP | None listed |
| Nov 21, 2025 | Foundation Medicine, Inc. FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Open, Classified |
PQP | None listed |
| Sep 4, 2025 | CARIS LIFE SCIENCES MI Cancer Seek REF MSC000
UDI Code: (01)00860008613325(21)H5HJHDSXF
MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professiona Open, Classified |
PQP | None listed |
| May 30, 2025 | Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Open, Classified |
PQP | None listed |
| May 30, 2025 | Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Open, Classified |
PQP | None listed |
| May 12, 2025 | Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Open, Classified |
PQP | None listed |
| Apr 11, 2023 | AGILENT TECHNOLOGIES INC./US Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 Open, Classified |
PQP | 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 |
| Aug 8, 2019 | Foundation Medicine, Inc. FoundationOne CDx test report Terminated |
PQP | None listed |
| Dec 20, 2018 | Foundation Medicine, Inc. FoundationOne CDx Test Results Terminated |
PQP | None listed |
| 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 |
| 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 |
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