Panels › Clinical Chemistry › Product code JJH · Class 1
Clinical Sample Concentrator
Regulation 862.2310
0510(k)s in 12 months (15 all time)
1recalls in 12 months (32 all time)
5recalls that name a 510(k)
Top companies in JJH
| Company | 510(k)s | Recalls |
|---|---|---|
| Entopsis , Inc. | 0 | 7 |
| Amicon, Inc. | 6 | 0 |
| Qiagen Sciences LLC | 0 | 6 |
| Abbott Molecular | 0 | 5 |
| Roche Molecular Systems, Inc. | 0 | 5 |
| Becton Dickinson & Co. | 0 | 3 |
| Vivascience, Inc. | 3 | 0 |
| BioMerieux SA | 0 | 2 |
| Clinical Micro Sensors, Inc. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | BioMerieux SA EMAG system
Model/Catalog Number: 418591/418591U
Product Description: Nucleic acid sample preparation instrument IVD, automated Open, Classified |
JJH | None listed |
| Jul 12, 2024 | Qiagen Sciences LLC QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications.
Model/Catalog Number: 9003 Open, Classified |
JJH | None listed |
| Apr 10, 2024 | Qiagen Sciences LLC EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications.
Model Number: 9003230 Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety o Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological sa Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transp Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of m Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples Open, Classified |
JJH | None listed |
| Dec 7, 2022 | Qvella Corporation The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The car Open, Classified |
JJH | None listed |
| Nov 21, 2021 | Qiagen Sciences LLC QIAcube Connect MDx, Model No. 9003070 Open, Classified |
JJH | None listed |
| Jun 3, 2020 | Roche Molecular Systems, Inc. MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purific Terminated |
JJH | None listed |
| Aug 1, 2019 | Qiagen Sciences LLC Filter-Tips, 1500 ul (1024 tips/kitbox),
REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024
Used in sample preparation Terminated |
JJH | None listed |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max ExK TNA 2;
Catalog # 442825 Terminated |
JJH | None listed |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max ExK DNA 2 USA;
Catalog # 442819 Terminated |
JJH | None listed |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max ExK DNA 1 USA;
Catalog # 442817 Terminated |
JJH | None listed |
| Jul 2, 2019 | Qiagen Sciences LLC QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD)
Model Number: 9001297
Pro Open, Classified |
JJH | None listed |
| Jul 23, 2018 | Qiagen Sciences LLC EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760
Product Usage:
The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used Terminated |
JJH | None listed |
| May 28, 2018 | QIAGEN EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. Terminated |
JJH | None listed |
| May 14, 2018 | Merck Millipore Ltd. Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15)
Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration Terminated |
JJH | None listed |
| May 2, 2018 | Roche Molecular Systems, Inc. MagNA Pure 24 System, GMMI: 07290519001
Product Usage:
The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and Terminated |
JJH | None listed |
| Apr 10, 2017 | bioMerieux, Inc. eMAG System, Ref 418591
It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, Terminated |
JJH | None listed |
| Apr 27, 2016 | Roche Molecular Systems, Inc. Hand-Held Scanner USB IT3800
For sample identification and tracking when used with various systems Terminated |
JJH | None listed |
| Jan 9, 2015 | Abbott Molecular The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. Terminated |
JJH | K092705 |
| Nov 25, 2014 | Abbott Molecular Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing. Terminated |
JJH | K092705 |
| Aug 8, 2014 | Abbott Molecular 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by pol Terminated |
JJH | K092705 |
| Dec 18, 2013 | Roche Diagnostics Operations, Inc. MagNA Pure 96 System
Version 1.0
Software Version 2.0
Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, cult Terminated |
JJH | None listed |
| Jan 3, 2013 | Abbott Molecular Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; a Terminated |
JJH | K092705 |
| Dec 23, 2012 | Roche Molecular Systems, Inc. COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5
Automated sample processing instrument used with CAP/CA and CAP/CTM.
Roche Molecular Systems, Inc.
1080 US Highway 202 South
Bra Terminated |
JJH | None listed |
| Jan 11, 2012 | Abbott Molecular Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 Terminated |
JJH | K092705 |
| Aug 27, 2009 | Roche Molecular Systems, Inc. AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 0509323 Terminated |
JJH | None listed |
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