Kit, Fastidious Organisms
FDA product code JST · Class I (low risk) · 21 CFR 866.2660 · Microbiology
6510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962423 | Bblcrystal Neisseria/Haemophilus (N/H) SystemJST · Traditional | Becton Dickinson Microbiology Systems | 08/02/1996SE |
| K854732 | Api 50 CHB (Culture Media)JST · Traditional | Dms Products, Inc. | 03/04/1986SE |
| K841661 | Synthetic Broth A.O.A.C.JST · Traditional | Oxoid U.S.A., Inc. | 05/11/1984SE |
| K832239 | Rim-Haemophilus 2JST · Traditional | Austin Biological Laboratories | 08/12/1983SE |
| K832051 | Rim-Haemophilus 1 & 2JST · Traditional | Austin Biological Laboratories | 08/12/1983SE |
| K831349 | Streptococus Id PlateJST · Traditional | Granite Diagnostics, Inc. | 05/16/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0794-2023 Class II | PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0793-2023 Class II | PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0791-2023 Class II | VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-2165-2018 Class II | The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | BioMerieux SA | 03/23/2018Terminated |
| Z-2874-2018 Class II | bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of…Missing desiccant. | Biomerieux Inc | 01/23/2018Terminated |
| Z-2345-2017 Class II | VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per…The integrity of the product container may be compromised thereby exposing product to moisture which could… | Biomerieux Inc | 04/20/2017Terminated |