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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Cardinal Health Presource Kits:
1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11;
2) CHI STD SPI...
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2
|
02/10/2025
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Cardinal Health 200, LLC
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BD PCR Cartridges used with MAX System. Model Number: 437519
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2
|
01/21/2025
|
Becton Dickinson & Co.
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BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngea...
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2
|
06/05/2024
|
Becton Dickinson & Co.
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The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for ...
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2
|
01/10/2024
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BioFire Diagnostics, LLC
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XScribe Cardiac Stress Testing System, version 6, with below product names and codes:
a) XS6/RS6 REV...
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2
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01/10/2024
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Baxter Healthcare Corporation
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Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes:
a) QS6 A...
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2
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01/10/2024
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Baxter Healthcare Corporation
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Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090.
The Alinity m HCV assay i...
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2
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11/29/2023
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Abbott Molecular, Inc.
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Procedure packs:
(1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile;
(2) Presource PBDS Cat. POC...
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2
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10/10/2023
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Cardinal Health 200, LLC
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therascreen ®KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument...
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2
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09/29/2023
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Qiagen GmbH
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QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Numbe...
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2
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06/02/2023
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Qiagen Sciences LLC
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PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
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2
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03/29/2023
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Entopsis , Inc.
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PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium...
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2
|
03/29/2023
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Entopsis , Inc.
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PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a varie...
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2
|
03/29/2023
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Entopsis , Inc.
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PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 5978...
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2
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03/29/2023
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Entopsis , Inc.
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PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF ...
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2
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03/29/2023
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Entopsis , Inc.
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PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the ...
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2
|
03/29/2023
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Entopsis , Inc.
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PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 783781...
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2
|
03/29/2023
|
Entopsis , Inc.
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Revogene SARS-CoV-2_IVD real-time RT-PCR test
intended for the qualitative detection of RNA from SA...
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2
|
01/20/2023
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Meridian Bioscience Inc
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cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) ...
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2
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10/17/2022
|
Roche Molecular Systems, Inc.
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FGFR RGQ RT-PCR Kit (RUO, not IVD)
REF 8747010
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2
|
08/29/2022
|
Qiagen Sciences LLC
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therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US)
REF 874711
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2
|
08/29/2022
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Qiagen Sciences LLC
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therascreen FGFR RGQ RT-PCR kit (US IVD)
REF 874721
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2
|
08/29/2022
|
Qiagen Sciences LLC
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therascreen KRAS RGQ PCR Kit (24)
Model Number(s): REF 870021 (US IVD)
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2
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04/19/2022
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Qiagen Sciences LLC
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therascreen KRAS RGQ PCR Kit (24)
REF 874052 (Japan IVD, not released in the USA)
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2
|
04/19/2022
|
Qiagen Sciences LLC
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Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A S...
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2
|
03/01/2022
|
Microbiologics Inc
|
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824
Subcomponent...
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2
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01/04/2022
|
Biomeme, Inc.
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Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization-
Ref: M124.
The Lyra Direct SARS-CoV-2 ...
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2
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09/15/2021
|
Quidel Corporation
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OPTI SARS-CoV-2 RT-PCR Test, REF Numbers:
a) 99-57003
b) 99-57004
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2
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08/17/2021
|
OPTI Medical Systems, Inc
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Revogene SARS-CoV-2
Catalog Number: 410700
IVD for real-time Reverse Transcription Polymerase C...
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2
|
05/07/2021
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Meridian Bioscience Inc
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BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of ...
|
2
|
04/13/2021
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Becton Dickinson & Co.
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Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancil...
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2
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04/07/2021
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Hologic, Inc
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BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic.
...
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2
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02/05/2021
|
Becton Dickinson & Co.
|
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo...
|
3
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02/01/2021
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Biomeme, Inc.
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therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer pati...
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2
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01/29/2021
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Qiagen Sciences LLC
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The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi...
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2
|
01/12/2021
|
Roche Molecular Systems, Inc.
|
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based o...
|
2
|
12/01/2020
|
Biomeme, Inc.
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The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2...
|
2
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09/17/2020
|
Life Technologies Corporation
|
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 750...
|
2
|
09/17/2020
|
Life Technologies Corporation
|
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
|
2
|
06/05/2020
|
Qiagen Sciences LLC
|
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycli...
|
2
|
03/12/2020
|
Qiagen Sciences LLC
|
Kit BD Max GC RT PCR Assay;
Catalog # 443486
|
2
|
08/22/2019
|
Becton Dickinson & Co.
|
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B
Product Usage:
used as a general purp...
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2
|
03/23/2019
|
LW Scientific, Inc.
|
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/...
|
2
|
02/12/2018
|
Cepheid
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Xpert EV Assay, Catalog GXEV-100N-10.
The Cepheid Xpert EV assay is a reverse transcription polym...
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2
|
10/18/2017
|
Cepheid
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LightMix® Zika rRT-PCR Test
The LightMix® Zika rRT-PCR Test is a real-time RT-PCR test intended for...
|
2
|
12/13/2016
|
Roche Molecular Systems, Inc.
|
cobas p 512 Pre-Analytical Instrument
calculator/data processing module, for clinical use
Produc...
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2
|
10/25/2016
|
Roche Diagnostics Operations, Inc.
|
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040...
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2
|
08/29/2016
|
Philips Electronics North America Corporation
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Zyston® Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
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2
|
08/11/2016
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Zimmer Biomet Spine, Inc
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Zyston® Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
|
2
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08/11/2016
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Zimmer Biomet Spine, Inc
|
cobas EGFR Mutation Test V2
Materials number
CE-IVD: EGFR v2: 07248563190
cfDNA: 07247737190
...
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2
|
07/21/2016
|
Roche Molecular Systems, Inc.
|
CytoScan® Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a mic...
|
3
|
06/03/2016
|
Affymetrix Inc
|
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204
...
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2
|
01/14/2015
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Biomet Spine, LLC
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LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.
Product Usage:...
|
2
|
12/16/2014
|
Biomet Spine LLC.
|
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta...
|
2
|
09/23/2014
|
Nanosphere, Inc.
|
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di...
|
2
|
09/23/2014
|
Nanosphere, Inc.
|
JBAIDS Instrument System Software version 3.5.0.72.
The JBAIDS instrument is a portable thermocyc...
|
3
|
09/15/2014
|
Biofire Defense
|
Nanosphere Verigene
Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen...
|
3
|
08/08/2014
|
Nanosphere, Inc.
|
cobas® PCR Urine Kit 100 PKT IVD
cobas® PCR Female Swab Kit 100 PKT IVD
cobas® PCR media 100T IVD
...
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2
|
02/26/2014
|
Roche Molecular Systems, Inc.
|
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; label...
|
2
|
01/17/2014
|
Becton Dickinson & Co.
|
MagNA Pure 96 System
Version 1.0
Software Version 2.0
Robotic workstation for automated isolati...
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2
|
12/18/2013
|
Roche Diagnostics Operations, Inc.
|
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD
Roche Molecular System, Inc. 1080 US highway ...
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2
|
09/10/2013
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Roche Molecular Systems, Inc.
|
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225)
Product Usage: Test is intended for u...
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2
|
05/14/2013
|
QIAGEN Gaithersburg, Inc.
|
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)
Product Usage: The artus CMV RG PCR A...
|
2
|
05/14/2013
|
QIAGEN Gaithersburg, Inc.
|
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges...
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2
|
03/22/2013
|
Becton Dickinson & Co.
|
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection a...
|
2
|
12/07/2012
|
Roche Molecular Systems, Inc.
|
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quant...
|
2
|
12/07/2012
|
Roche Molecular Systems, Inc.
|
Data Station AMPLILINK software is an instrument user interface/ data management software used with ...
|
2
|
12/07/2012
|
Roche Molecular Systems, Inc.
|
Knee Components:
ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380
INSERT TIBIAL "913...
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2
|
10/31/2012
|
Wright Medical Technology Inc
|
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, In...
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2
|
09/06/2012
|
Becton Dickinson & Co.
|
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences C...
|
2
|
09/06/2012
|
Becton Dickinson & Co.
|
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 b...
|
2
|
09/06/2012
|
Becton Dickinson & Co.
|
Cobas KRAS Mutation Test for In Vitro Diagnostic Use
Product Usage: Usage:
The Cobas KRAS Mutat...
|
3
|
08/08/2012
|
Roche Molecular Systems, Inc.
|
Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that resul...
|
2
|
10/14/2011
|
Abbott Molecular
|
PCR Eleva Radiological Image Processing System with software R.1.2
Philips Healthcare, Inc.
A c...
|
2
|
09/14/2011
|
Philips Healthcare Inc.
|
MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)
Roche Diagnostics Operations, Inc.
An aut...
|
2
|
08/29/2011
|
Roche Diagnostics Operations, Inc.
|
MagNA Pure LC 1.0 (software version 3.0.11).
Roche Diagnostics Operations, Inc.
An automated ins...
|
2
|
08/29/2011
|
Roche Diagnostics Operations, Inc.
|
Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, In...
|
2
|
06/14/2011
|
Roche Molecular Systems, Inc.
|
Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molec...
|
2
|
06/14/2011
|
Roche Molecular Systems, Inc.
|
Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN
The Factor ...
|
2
|
03/14/2011
|
Roche Diagnostics Operations, Inc.
|
MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN
M...
|
2
|
03/14/2011
|
Roche Diagnostics Operations, Inc.
|
Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis,...
|
2
|
03/14/2011
|
Roche Diagnostics Operations, Inc.
|
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60...
|
3
|
02/23/2011
|
Abbott Molecular
|
Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ...
|
3
|
02/23/2011
|
Abbott Molecular
|
Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ...
|
3
|
02/23/2011
|
Abbott Molecular
|
PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Ph...
|
2
|
02/04/2011
|
Philips Medical Systems North America Co. Phillips
|
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA.
Indicated as a...
|
3
|
05/25/2010
|
Cepheid
|
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA.
Indicated a...
|
3
|
05/25/2010
|
Cepheid
|
BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test fo...
|
2
|
10/31/2008
|
BD Diagnostics (GeneOhm Sciences, Inc)
|
BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test ...
|
2
|
10/31/2008
|
BD Diagnostics (GeneOhm Sciences, Inc)
|
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V...
|
2
|
09/16/2008
|
Philips Medical Systems North America Co. Phillips
|
Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrume...
|
2
|
08/05/2006
|
Roche Diagnostics Corp.
|
Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690...
|
2
|
08/05/2006
|
Roche Diagnostics Corp.
|
Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument...
|
2
|
08/05/2006
|
Roche Diagnostics Corp.
|
Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification...
|
2
|
04/19/2006
|
Roche Diagnostics Corp.
|
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
|
2
|
08/17/2005
|
Cepheid
|
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutio...
|
2
|
09/23/2003
|
International Surgical Supply, Inc.
|