JSE · Culture Media, Multiple Biochemical Test
Microbiology · 21 CFR 866.2320 · Class 1
Overview
| Product Code | JSE |
|---|---|
| Device Name | Culture Media, Multiple Biochemical Test |
| Regulation | 21 CFR 866.2320 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962265 | MLX MICROTITER PLATE LUMINOMETER | Dynatech Laboratories, Inc. | Jul 25, 1996 | SESE |
| K883996 | X-ACT LDC/IND | Pro-Lab, Inc. | Oct 12, 1988 | SESE |
| K883995 | X-ACT UREA/TDA | Pro-Lab, Inc. | Oct 12, 1988 | SESE |
| K880133 | MIL MEDIUM | Hardy Media | Mar 31, 1988 | SESE |
| K880116 | MRVP BROTH | Hardy Media | Mar 31, 1988 | SESE |
| K874537 | KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR | Lakewood Biochemical Co., Inc. | Nov 20, 1987 | SESE |
| K871096 | CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES | bioMerieux, Inc. | Apr 3, 1987 | SESE |
| K864674 | MICRODILUTION IDENTIFICATION PANELS | American Micro Scan | Jan 5, 1987 | SESE |
| K862393 | BIOTIS LITMUS MILK | Otisville Biotech, Inc. | Jul 3, 1986 | SESE |
| K860415 | BIOTIS SIMMON CITRATE AGAR | Otisville Biotech, Inc. | Feb 24, 1986 | SESE |
| K860414 | BIOTIS ORNITHINE INDOLE MOTILITY MEDIA | Otisville Biotech, Inc. | Feb 24, 1986 | SESE |
| K860413 | BIOTIS TSI | Otisville Biotech, Inc. | Feb 24, 1986 | SESE |
| K860412 | BIOTIS SIM MEDIUM | Otisville Biotech, Inc. | Feb 24, 1986 | SESE |
| K860194 | AUSTIN ENTERIC SYSTEM | Austin Biological Laboratories | Feb 20, 1986 | SESE |
| K850982 | CTAPI - NEISSERA SCREEN | Analytical Products, Inc. | Mar 29, 1985 | SESE |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | Roseville Medical Laboratoriesu | Mar 20, 1985 | SESE |
| K850551 | SIM MEDIUM | Hardy Media | Mar 11, 1985 | SESE |
| K850548 | LYSINE IRON AGAR LIA | Hardy Media | Mar 11, 1985 | SESE |
| K850547 | MOTILITY INDOLE ORNITHINE AGAR | Hardy Media | Mar 11, 1985 | SESE |
| K850546 | KLIGLER IRON AGAR KIA | Hardy Media | Mar 11, 1985 | SESE |
Top Applicants
- Hardy Media — 7 clearances
- Otisville Biotech, Inc. — 7 clearances
- Analytical Products, Inc. — 5 clearances
- Micro Media Laboratories — 5 clearances
- Isle Media and Sterile Products, Inc. — 3 clearances
