ClearanceBrief
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)
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Top companies in JJH

DateFirm and productCodeLinked 510(k)
Oct 27, 2026BioMerieux SA
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Open, Classified
JJHNone listed
Jul 12, 2024Qiagen 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
JJHNone listed
Apr 10, 2024Qiagen 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
JJHNone listed
Mar 29, 2023Entopsis , 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
JJHNone listed
Mar 29, 2023Entopsis , 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
JJHNone listed
Mar 29, 2023Entopsis , 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
JJHNone listed
Mar 29, 2023Entopsis , 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
JJHNone listed
Mar 29, 2023Entopsis , Inc.
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Open, Classified
JJHNone listed
Mar 29, 2023Entopsis , 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
JJHNone listed
Mar 29, 2023Entopsis , Inc.
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Open, Classified
JJHNone listed
Dec 7, 2022Qvella 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
JJHNone listed
Nov 21, 2021Qiagen Sciences LLC
QIAcube Connect MDx, Model No. 9003070
Open, Classified
JJHNone listed
Jun 3, 2020Roche 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
JJHNone listed
Aug 1, 2019Qiagen 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
JJHNone listed
Jul 17, 2019Becton Dickinson & Co.
Kit BD Max ExK TNA 2; Catalog # 442825
Terminated
JJHNone listed
Jul 17, 2019Becton Dickinson & Co.
Kit BD Max ExK DNA 2 USA; Catalog # 442819
Terminated
JJHNone listed
Jul 17, 2019Becton Dickinson & Co.
Kit BD Max ExK DNA 1 USA; Catalog # 442817
Terminated
JJHNone listed
Jul 2, 2019Qiagen 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
JJHNone listed
Jul 23, 2018Qiagen 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
JJHNone listed
May 28, 2018QIAGEN
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Terminated
JJHNone listed
May 14, 2018Merck 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
JJHNone listed
May 2, 2018Roche 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
JJHNone listed
Apr 10, 2017bioMerieux, 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
JJHNone listed
Apr 27, 2016Roche Molecular Systems, Inc.
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Terminated
JJHNone listed
Jan 9, 2015Abbott Molecular
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Terminated
JJHK092705
Nov 25, 2014Abbott Molecular
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Terminated
JJHK092705
Aug 8, 2014Abbott 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
JJHK092705
Dec 18, 2013Roche 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
JJHNone listed
Jan 3, 2013Abbott 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
JJHK092705
Dec 23, 2012Roche 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
JJHNone listed
Jan 11, 2012Abbott 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
JJHK092705
Aug 27, 2009Roche 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
JJHNone listed

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