Panels › Clinical Chemistry › Product code NSU · Class 2
Instrumentation For Clinical Multiplex Test Systems
Regulation 862.2570
0510(k)s in 12 months (13 all time)
2recalls in 12 months (14 all time)
6recalls that name a 510(k)
Top companies in NSU
| Company | 510(k)s | Recalls |
|---|---|---|
| Hologic, Inc | 0 | 4 |
| Luminex Corp. | 3 | 1 |
| Affymetrix, Inc. | 2 | 1 |
| Becton Dickinson & Co. | 0 | 3 |
| Biofire Diagnostics, LLC | 1 | 2 |
| GenMark Diagnostics, Inc. | 2 | 0 |
| Nuclein LLC | 0 | 2 |
| Applied Biosystems, Inc. | 1 | 0 |
| Illumina, Inc. | 1 | 0 |
| Liposcience | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2026 | Nuclein LLC Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6
Product Description: The DASH Rapid PCR Instrum Open, Classified |
NSU | K241652 |
| Aug 3, 2026 | Nuclein LLC Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2
Product Description: The DASH Rapid PCR Instrument (DASH Instrument) Open, Classified |
NSU | K241652 |
| Sep 11, 2024 | BioFire Diagnostics, LLC FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W Open, Classified |
NSU | K143178 |
| Nov 20, 2023 | BioFire Diagnostics, LLC FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports.
The BioFire FilmArray Torch (BioFire Torch) is an auto Open, Classified |
NSU | None listed |
| Oct 17, 2022 | Roche Molecular Systems, Inc. cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings. Terminated |
NSU | None listed |
| Feb 26, 2021 | Hologic, Inc Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the Open, Classified |
NSU | None listed |
| Aug 4, 2020 | Hologic, Inc Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 Terminated |
NSU | None listed |
| Apr 22, 2019 | Luminex Corporation Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R Open, Classified |
NSU | None listed |
| Jan 20, 2018 | Hologic, Inc Hologic Panther(R) Fusion(TM), Catalog number ASY-09600
Product Usage:
The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates Terminated |
NSU | K132251 |
| Sep 15, 2017 | Hologic, Inc Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use Terminated |
NSU | K132251 |
| Jul 18, 2017 | Becton Dickinson & Co. BD MAX" CT/GC/TV.
Catalog Number(s):
443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and femal Terminated |
NSU | K151589 |
| Jul 18, 2017 | Becton Dickinson & Co. BD MAX" UVE Specimen Collection Kit.
Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females Terminated |
NSU | None listed |
| Jul 18, 2017 | Becton Dickinson & Co. BD MAXTM Vaginal Panel. Catalog Number(s): 443712
443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and fe Terminated |
NSU | None listed |
| May 6, 2006 | Affymetrix, Inc. Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software Terminated |
NSU | None listed |
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