Panels › Microbiology › Product code JXB · Class 1
Kit, Identification, Yeast
Regulation 866.2660
0510(k)s in 12 months (16 all time)
0recalls in 12 months (6 all time)
2recalls that name a 510(k)
Top companies in JXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomerieux Inc | 0 | 4 |
| Remel Co. | 2 | 2 |
| Advandx, Inc. | 2 | 0 |
| Analytical Products, Inc. | 2 | 0 |
| Vitek Systems, Inc. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Diagnostic Markers, Inc. | 1 | 0 |
| Diagnostica, Inc. | 1 | 0 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 Open, Classified |
JXB | None listed |
| Jan 4, 2023 | Biomerieux Inc API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210 Open, Classified |
JXB | None listed |
| Dec 20, 2021 | Biomerieux Inc API ID 32 C Strips, Reference 32200, Rx Only, IVD
API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database Terminated |
JXB | None listed |
| May 22, 2017 | Biomerieux Inc VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. . Terminated |
JXB | None listed |
| Dec 17, 2013 | Remel Inc remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B.
Product Usage: For the bioch Terminated |
JXB | K943621 |
| Feb 26, 2010 | Remel, Inc ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic Terminated |
JXB | K943621 |
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