Culture Media, Multiple Biochemical Test
FDA product code JSE · Class I (low risk) · 21 CFR 866.2320 · Microbiology
53510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Otisville Biotech, Inc. 7
- Hardy Media 7
- Micro Media Laboratories 5
- Analytical Products, Inc. 5
- Isle Media and Sterile Products, Inc. 3
- Blue Ridge Media Co. 2
- Pro-Lab, Inc. 2
- Austin Biological Laboratories 2
- Granite Diagnostics, Inc. 2
- Carr Microbiologicals 2
- Los Angeles Biological Products 2
- Anaerobe Systems 2
- Biomedica, Inc. 1
- Dms Laboratories 1
- Gibco Laboratories Life Technologies, Inc. 1
- Acumedia Manufacturers, Inc. 1
- Remel Co. 1
- Smith River Biologicals 1
- Roseville Medical Laboratoriesu 1
- Dynatech Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | Dynatech Laboratories, Inc. | 07/25/1996SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K880133 | Mil MediumJSE · Traditional | Hardy Media | 03/31/1988SE |
| K880116 | MRVP BrothJSE · Traditional | Hardy Media | 03/31/1988SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | Lakewood Biochemical Co., Inc. | 11/20/1987SE |
| K871096 | Cystine Tryptic Agar W/O CarbohydratesJSE · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | American Micro Scan | 01/05/1987SE |
| K862393 | Biotis Litmus MilkJSE · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K860415 | Biotis Simmon Citrate AgarJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860414 | Biotis Ornithine Indole Motility MediaJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860413 | Biotis TsiJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860412 | Biotis Sim MediumJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860194 | Austin Enteric SystemJSE · Traditional | Austin Biological Laboratories | 02/20/1986SE |
| K850982 | Ctapi - Neissera ScreenJSE · Traditional | Analytical Products, Inc. | 03/29/1985SE |
| K850734 | Differential Culture MediumJSE · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
| K850551 | Sim MediumJSE · Traditional | Hardy Media | 03/11/1985SE |
| K850548 | Lysine Iron Agar LiaJSE · Traditional | Hardy Media | 03/11/1985SE |
| K850547 | Motility Indole Ornithine AgarJSE · Traditional | Hardy Media | 03/11/1985SE |
| K850546 | Kligler Iron Agar KiaJSE · Traditional | Hardy Media | 03/11/1985SE |
| K843768 | Biotis Kligler Iron AgarJSE · Traditional | Otisville Biotech, Inc. | 10/10/1984SE |
| K842451 | Rim Strep KitJSE · Traditional | Austin Biological Laboratories | 07/02/1984SE |
| K842424 | Biotis Ld-Presumpto Quadrant PlateJSE · Traditional | Otisville Biotech, Inc. | 07/02/1984SE |
| K841204 | Multiple Biochemical TestJSE · Traditional | Smith River Biologicals | 04/17/1984SE |
| K834012 | Sim MediumJSE · Traditional | Micro Media Laboratories | 12/22/1983SE |
| K834004 | Mycobiotic AgarJSE · Traditional | Micro Media Laboratories | 12/22/1983SE |
| K834003 | Motility Indole Ornithine-MediumJSE · Traditional | Micro Media Laboratories | 12/22/1983SE |
| K834002 | Lysine Iron AgarJSE · Traditional | Micro Media Laboratories | 12/22/1983SE |
| K834001 | Kligler Iron AgarJSE · Traditional | Micro Media Laboratories | 12/22/1983SE |
| K832568 | Indole Nitrate MediumJSE · Traditional | Acumedia Manufacturers, Inc. | 09/12/1983SE |
| K830525 | Api 20GPJSE · Traditional | Analytical Products, Inc. | 05/18/1983SE |
| K822998 | Christensens Citrate Sulfide AgarJSE · Traditional | Granite Diagnostics, Inc. | 11/16/1982SE |
| K823072 | Lecithin Lactose AgarJSE · Traditional | Granite Diagnostics, Inc. | 11/05/1982SE |
| K821592 | Triple Sugar Iron Agar SlantJSE · Traditional | Hardy Media | 07/08/1982SE |
| K820842 | Culture Media, Non-Selective/DifferJSE · Traditional | Blue Ridge Media Co. | 04/16/1982SE |
| K820841 | Culture Media, Multiple BiochemicalJSE · Traditional | Blue Ridge Media Co. | 04/16/1982SE |
| K820810 | #4004 Triple Sugar Iron Agar Slants-TubeJSE · Traditional | Biomedica, Inc. | 04/08/1982SE |
| K820214 | SucroseJSE · Traditional | Dms Laboratories | 02/05/1982SE |
| K812911 | Bcye MediumJSE · Traditional | Gibco Laboratories Life Technologies, Inc. | 11/06/1981SE |
| K812467 | Pgua-Indol MicrotubeJSE · Traditional | Carr Microbiologicals | 09/14/1981SE |
| K812466 | Onpx-Indol Medium MicrotubesJSE · Traditional | Carr Microbiologicals | 09/14/1981SE |
| K800734 | Rapid Fermentation Agar (Rfa)JSE · Traditional | Remel Co. | 05/08/1980SE |
| K792420 | Sim MediumJSE · Traditional | Isle Media and Sterile Products, Inc. | 12/31/1979SE |
| K792425 | Decarboxylase Moeller Base with or With-JSE · Traditional | Isle Media and Sterile Products, Inc. | 12/27/1979SE |
| K791473 | Triple Sugar Iron Agar (Tsi Agar)JSE · Traditional | Isle Media and Sterile Products, Inc. | 08/22/1979SE |
| K791222 | Api 20E Reagent QCJSE · Traditional | Analytical Products, Inc. | 08/22/1979SE |
| K790617 | Carbohydrate Fermentation MediaJSE · Traditional | Anaerobe Systems | 04/23/1979SE |
| K790232 | Agar, Motility-NitrateJSE · Traditional | Los Angeles Biological Products | 02/21/1979SE |
| K790230 | Dentrification Lactose AgarJSE · Traditional | Los Angeles Biological Products | 02/21/1979SE |
| K781856 | Plate, LD PresumptoJSE · Traditional | Anaerobe Systems | 11/22/1978SE |
| K770989 | Api 50 EJSE · Traditional | Analytical Products, Inc. | 06/29/1977SE |
| K770746 | Panel, Identification, Strep, Micro-IdJSE · Traditional | Micro-Media Systems, Inc. | 06/23/1977SE |
| K770176 | Api 3SJSE · Traditional | Analytical Products, Inc. | 02/18/1977SE |