ClearanceBrief
Panels › Microbiology › Product code LON · Class 2

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Regulation 866.1645

4510(k)s in 12 months (291 all time)
6recalls in 12 months (240 all time)
161recalls that name a 510(k)
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Top companies in LON

DateFirm and productCodeLinked 510(k)
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimi
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimi
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimic
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qua
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitat
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative an
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobi
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobia
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimic
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial age
Terminated
LONK020246
K020249
Sep 11, 2013Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobia
Terminated
LONK020246
K020249
Dec 19, 2012Becton Dickinson & Co.
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rap
Terminated
LONK070809
May 24, 2012Becton Dickinson & Co.
Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: The Phoenix
Terminated
LONK030677
May 24, 2012Becton Dickinson & Co.
Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microb
Terminated
LONK030677
Apr 27, 2011Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'E
Terminated
LONK080107
Apr 27, 2011Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'E
Terminated
LONK080107
Mar 30, 2011Becton Dickinson & Co.
BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** The BD Phoenix
Terminated
LONK033458
Nov 15, 2010Becton Dickinson & Co.
BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
Terminated
LONK021954
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N107, REF 22 265, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONNone listed
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-GN44, REF 410 805, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-GN40, REF 410 756, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONNone listed
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N182, REF 410 804, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N181, REF 410 803, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N180, REF 410 771, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N179, REF 410 640, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N178, REF 410 393, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N177, REF 410 392, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N176, REF 410 402, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N175, REF 410 403, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N174, REF 410 404, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N170, REF 410 222, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N168, REF 410 139, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N166, REF 410 136, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N165, REF 410 102, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N164, REF 410 101, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N163, REF 410 084, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N162, REF 410 023, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N161, REF 410 026, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N160, REF 22 357, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N159, REF 22 356, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N158, REF 22 355, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N157, REF 22 354, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N156, REF 22 353, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N155, REF 22 352, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N153, REF 22 348, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107
Nov 11, 2010Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N152, REF 22 347, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar
Terminated
LONK080107

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