Panels › Microbiology › Product code LTW · Class 2
Susceptibility Test Cards, Antimicrobial
Regulation 866.1640
0510(k)s in 12 months (16 all time)
1recalls in 12 months (39 all time)
2recalls that name a 510(k)
Top companies in LTW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | Biomerieux Inc VITEK 2 Gram-negative Susceptibility Cards Containing
o Polymyxin B (pb02n)
o Ceftazidime/avibactam (cza02n)
o Meropenem/Vaborbactam (mev01n)
o Imipenem (ipm05n)
o Imipenem/Relebactam (ipr01n);
CARD Open, Classified |
LTW | K172944 K183360 +3 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 Open, Classified |
LTW | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 Open, Classified |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinic Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinica Terminated |
LTW | None listed |
| May 11, 2016 | Biomerieux Inc Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit.
Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical Terminated |
LTW | None listed |
| May 12, 2015 | Biomerieux Inc Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibi Terminated |
LTW | None listed |
| May 12, 2015 | Biomerieux Inc Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptib Terminated |
LTW | None listed |
| May 12, 2015 | Biomerieux Inc Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibil Terminated |
LTW | None listed |
| Apr 8, 2015 | Biomerieux Inc Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the sus Terminated |
LTW | None listed |
| Apr 8, 2015 | Biomerieux Inc Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the Terminated |
LTW | None listed |
| Apr 8, 2015 | Biomerieux Inc Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773.
The product is used with the VITEK 2 automate Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568.
The product is used with the VITEK 2 automated syst Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567.
The product is used with the VITEK 2 automated syst Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537.
The product is used with the VITEK 2 automated system w Terminated |
LTW | None listed |
| Aug 6, 2013 | Biomerieux Inc bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861.
The product is used with the VITEK 2 automate Terminated |
LTW | None listed |
| Mar 27, 2013 | Biomerieux Inc bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028.
For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. Terminated |
LTW | None listed |
| Mar 25, 2013 | Biomerieux Inc VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models:
(1) dc7100 8-port, Cat. #W0441;
(2) dc7100 8-port (refurbished), Cat. #W0441R;
(3) dc7700 8-port, Cat. #W Terminated |
LTW | K050002 |
| Mar 25, 2013 | Biomerieux Inc VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models:
(1) rp5700, Cat. #W0452;
(2) rp5700 (refurbished), Cat. #W0452R;
(3) rp5800 XPE, Cat. 413642;
(4) rp5800 WES7, C Terminated |
LTW | None listed |
| Mar 25, 2013 | Biomerieux Inc VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models:
(1) rp5700, Cat. #W0452;
(2) rp5700 (refurbished), Cat. #W0452R;
(3) rp5800 XPE, Cat. 413642;
(4) rp5800 WES7, C Terminated |
LTW | None listed |
| Jul 9, 2011 | Biomerieux Inc VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228).
VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identific Terminated |
LTW | None listed |
| Jul 9, 2011 | Biomerieux Inc VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226).
VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identific Terminated |
LTW | None listed |
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