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Panels › Microbiology › Product code JWY · Class 2

Manual Antimicrobial Susceptibility Test Systems

Regulation 866.1640

2510(k)s in 12 months (441 all time)
0recalls in 12 months (78 all time)
77recalls that name a 510(k)
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Top companies in JWY

Company510(k)sRecalls
Ab Biomerieux1549
Ab Biodisk610
Trek Diagnostic Systems510
Thermo Fisher Scientific470
Pasco Laboratories, Inc.390
Liofilchem s.r.l.350
Bd Becton Dickinson Vacutainer Systems Preanalytic320
Dade Microscan, Inc.260
Alamar Biosciences Laboratory, Inc.220
Beckman Coulter, Inc.410
DateFirm and productCodeLinked 510(k)
Jan 18, 2017BioMerieux SA
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteri
Terminated		 JWYK990722
Dec 23, 2015Biomerieux
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Terminated		 JWYK953223
Dec 23, 2015Biomerieux
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Terminated		 JWYK953223
Dec 23, 2015Biomerieux
Etest PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Terminated		 JWYK953223
Dec 23, 2015Biomerieux
Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic
Terminated		 JWYK953223
Dec 23, 2015Becton Dickinson & Co.
Enterococcus Screen Agar QUAD Plate
Terminated		 JWYK951539
Dec 23, 2015Becton Dickinson & Co.
Vancomycin Screen Agar
Terminated		 JWYK951539
Jul 1, 2015BioMerieux SA
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Terminated		 JWYK981137
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent s
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ESL plus, Catalog B1027-101 Microbiology: For u
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbio
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbio
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiol
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology
Terminated		 JWYK870074
Apr 27, 2015Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: F
Terminated		 JWYK870074
Apr 26, 2015Beckman Coulter, Inc.
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial
Terminated		 JWYK862140
Nov 19, 2014Biomerieux
Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic
Terminated		 JWYK121002
Nov 19, 2014Biomerieux
Etest Ceftaroline (CPT32) US B100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic
Terminated		 JWYK121002
Nov 19, 2014Biomerieux
Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic
Terminated		 JWYK121002
Nov 19, 2014Biomerieux
Etest Ceftaroline (CPT32) WWB100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic
Terminated		 JWYK121002
Nov 19, 2014Biomerieux
Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic
Terminated		 JWYK121002
Sep 12, 2014Becton Dickinson & Co.
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with
Terminated		 JWYK951539
Jul 24, 2013Becton Dickinson & Co.
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin S
Terminated		 JWYK951539
May 8, 2012Siemens Healthcare Diagnostics, Inc.
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Siemens Healthcare Diagnostics, West Sacramento, CA. For use in determining qua
Terminated		 JWYK862140
May 8, 2012Siemens Healthcare Diagnostics, Inc.
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.
Terminated		 JWYK862140
May 8, 2012Siemens Healthcare Diagnostics, Inc.
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.
Terminated		 JWYK862140
Feb 4, 2009Siemens Microscan
MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to t
Terminated		 JWYK870074

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