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)
Top companies in LON
| Company | 510(k)s | Recalls |
|---|---|---|
| BIOMERIEUX | 116 | 192 |
| Becton Dickinson & Company | 107 | 29 |
| Dade Behring, Inc. | 37 | 1 |
| Becton, Dickinson and Co. | 15 | 0 |
| Siemens Healthcare Diagnostics | 1 | 13 |
| Bd Diagnostic Systems | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 2 |
| Biomérieux, Inc. | 2 | 0 |
| Copan Wasp Srl | 2 | 0 |
| Dade Microscan, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2018 | BioMerieux SA The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enteroco Terminated |
LON | None listed |
| Jul 12, 2017 | Biomerieux Inc VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing Terminated |
LON | K050002 |
| Jul 12, 2017 | Biomerieux Inc VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast. Terminated |
LON | K050002 |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN93), REF 414985, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN91), REF 414780, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-XN06), REF 413944, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN86), REF 413942, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN74), REF 413941, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN83), REF 413440, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN82), REF 413439, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN81), REF 413438, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN75), REF 413432, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN84), REF 413410, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN73), REF 413404, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN71), REF 413402, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN66), REF 413398, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-GP68), REF 22231, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton. Terminated |
LON | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton. Terminated |
LON | None listed |
| May 11, 2017 | Becton Dickinson & Co. BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD.
PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The indu Terminated |
LON | K082538 |
| Jun 1, 2016 | Becton Dickinson & Co. PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standar Terminated |
LON | K023301 |
| Jun 1, 2016 | Becton Dickinson & Co. PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland stan Terminated |
LON | K023301 |
| May 3, 2016 | Biomerieux Inc VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712.
VITEK 2 is an automated system consisting of instruments, software, Terminated |
LON | None listed |
| Nov 7, 2014 | Siemens Healthcare Diagnostics, Inc. Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167;
Siemens Material Number 10444652
MicroScan Rapid panels are designed for use in determining identification to the species level and/or a Terminated |
LON | None listed |
| Nov 7, 2014 | Siemens Healthcare Diagnostics, Inc. Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117.
MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of Terminated |
LON | None listed |
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