JSH · Culture Media, Non-Selective And Differential
Microbiology · 21 CFR 866.2320 · Class 1
Overview
| Product Code | JSH |
|---|---|
| Device Name | Culture Media, Non-Selective And Differential |
| 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 146)
Showing 20 most recent of 146 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881560 | UREA BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881559 | UREA AGAR BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881553 | RUSSELL DOUBLE SUGAR AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881551 | PHENOL RED BROTH BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881540 | FLO AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881486 | DNASE TEST AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K880121 | MOELLERS DECARBOXYLASE, BASE | Hardy Media | Mar 31, 1988 | SESE |
| K880117 | OF MEDIUM BASE | Hardy Media | Mar 30, 1988 | SESE |
| K873270 | ACTINOMYCETE DIFFERENTIAL MEDIA | Central Media | Nov 4, 1987 | SESE |
| K873263 | MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA | Central Media | Oct 28, 1987 | SESE |
| K873411 | SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 | Lakewood Biochemical Co., Inc. | Oct 6, 1987 | SESE |
| K873704 | MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 | Lakewood Biochemical Co., Inc. | Oct 2, 1987 | SESE |
| K873703 | LYSINE IRON AGAR (LIA) PRODUCT #T3046 | Lakewood Biochemical Co., Inc. | Oct 2, 1987 | SESE |
| K872670 | IAFP MAC CONKEY AGAR | I.A.F. Production, Inc. | Aug 11, 1987 | SESE |
| K872020 | MUCATE AGAR, SLANTS AND MUCATE BROTH | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 2, 1987 | SESE |
| K871855 | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM | Gibco Laboratories Life Technologies, Inc. | May 26, 1987 | SESE |
| K871701 | ARYLSULFATASE BROTH | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 20, 1987 | SESE |
| K870651 | BIGGY AGAR | Hardy Media | Apr 14, 1987 | SESE |
| K870636 | HEMOPHILUS ID QUAD PLATE | Hardy Media | Apr 14, 1987 | SESE |
| K871095 | CLED AGAR | bioMerieux, Inc. | Apr 3, 1987 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 21 clearances
- Isle Media and Sterile Products, Inc. — 17 clearances
- bioMerieux, Inc. — 12 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 10 clearances
- Otisville Biotech, Inc. — 9 clearances
