JSF · Culture Media, Single Biochemical Test
Microbiology · 21 CFR 866.2320 · Class 1
Overview
| Product Code | JSF |
|---|---|
| Device Name | Culture Media, Single 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 87)
Showing 20 most recent of 87 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880946 | NUTRIENT GELATIN - PRODUCT NUMBER T2860 | Lakewood Biochemical Co., Inc. | Apr 1, 1988 | SESE |
| K880126 | LAURYL TRYPTOSE BROTH | Hardy Media | Mar 31, 1988 | SESE |
| K880120 | MOELLERS DECARBOXYLASE, LYSINE | Hardy Media | Mar 31, 1988 | SESE |
| K880119 | MOELLERS DECARBOXYLASE, ONITHINE | Hardy Media | Mar 31, 1988 | SESE |
| K880139 | ONPG TEST REAGENT | Hardy Media | Mar 30, 1988 | SESE |
| K880135 | NITRATE BROTH | Hardy Media | Mar 30, 1988 | SESE |
| K880129 | BRILLIANT GREEN BILE BROTH | Hardy Media | Mar 30, 1988 | SESE |
| K880118 | MOELLOERS DECARBOXYLASE, ARGININE | Hardy Media | Mar 30, 1988 | SESE |
| K880113 | CYSTINE TRYPTIC MEDIUM W/LACTOSE | Hardy Media | Mar 30, 1988 | SESE |
| K880112 | CYSTINE TRYPTIC MEDIUM W/ MALTOSE | Hardy Media | Mar 30, 1988 | SESE |
| K880111 | CYSTINE TRYPTIC MEDIUM W/SUCROSE | Hardy Media | Mar 30, 1988 | SESE |
| K880110 | CYSTINE TRYPTIC MEDIUM W/DEXTROSE | Hardy Media | Mar 30, 1988 | SESE |
| K880106 | ACETAMIDE AGAR SLANT | Hardy Media | Mar 30, 1988 | SESE |
| K880115 | NUTRIENT GELATIN | Hardy Media | Mar 8, 1988 | SESE |
| K874175 | BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC | Otisville Biopharm, Inc. | Dec 4, 1987 | SESE |
| K874174 | BIOTIS (TM) STARCH HYDROLYSIS WITH BCP | Otisville Biopharm, Inc. | Dec 4, 1987 | SESE |
| K873828 | CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990 | Lakewood Biochemical Co., Inc. | Oct 6, 1987 | SESE |
| K872691 | IAFP UREA AGAR SLANT | I.A.F. Production, Inc. | Aug 11, 1987 | SESE |
| K870641 | TRYPTONE BROTH, 2% | Hardy Media | Apr 14, 1987 | SESE |
| K864256 | TRYPTONE WATER (1%) | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
Top Applicants
- Hardy Media — 20 clearances
- Irvine Diagnostic Services — 10 clearances
- bioMerieux, Inc. — 7 clearances
- Granite Diagnostics, Inc. — 7 clearances
- Remel Co. — 4 clearances
