ClearanceBrief
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)
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Top companies in LTW

DateFirm and productCodeLinked 510(k)
Feb 2, 2026Biomerieux 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
LTWK172944
K183360 +3
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Open, Classified
LTWNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Open, Classified
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 11, 2016Biomerieux 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
LTWNone listed
May 12, 2015Biomerieux 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
LTWNone listed
May 12, 2015Biomerieux 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
LTWNone listed
May 12, 2015Biomerieux 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
LTWNone listed
Apr 8, 2015Biomerieux 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
LTWNone listed
Apr 8, 2015Biomerieux 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
LTWNone listed
Apr 8, 2015Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Aug 6, 2013Biomerieux 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
LTWNone listed
Mar 27, 2013Biomerieux 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
LTWNone listed
Mar 25, 2013Biomerieux 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
LTWK050002
Mar 25, 2013Biomerieux 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
LTWNone listed
Mar 25, 2013Biomerieux 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
LTWNone listed
Jul 9, 2011Biomerieux 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
LTWNone listed
Jul 9, 2011Biomerieux 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
LTWNone listed

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