JTY · Culture Media, For Isolation Of Pathogenic Neisseria
Microbiology · 21 CFR 866.2410 · Class 2
Overview
| Product Code | JTY |
|---|---|
| Device Name | Culture Media, For Isolation Of Pathogenic Neisseria |
| Regulation | 21 CFR 866.2410 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A culture medium for pathogenic Neisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic Neisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 83)
Showing 20 most recent of 83 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210511 | InTray GC | Biomed Diagnostics Incorporated | Oct 20, 2021 | SESE |
| K993033 | INTRAY GC | Biomed Diagnostics, Inc. | Dec 16, 1999 | SESE |
| K954986 | GC BASE W/ 1% GCHI | Remel, L.P. | Feb 16, 1996 | SESE |
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Bioclinical Systems, Inc. | Jun 30, 1995 | SESE |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Bioclinical Systems, Inc. | Feb 9, 1994 | SESE |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Bioclinical Systems, Inc. | Feb 3, 1994 | SESE |
| K934331 | THAYER MARTIN, MODIFIED PILL POCKET | Hardy Diagnostics | Dec 21, 1993 | SESE |
| K934330 | TRANSGROW | Hardy Diagnostics | Dec 17, 1993 | SESE |
| K931864 | MARTIN LEWIS WITH LINOCMYCIN | Hardy Diagnostics | Dec 15, 1993 | SESE |
| K881552 | PROTEOSE NO. 3 AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881527 | CASMAN MEDIUM BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | Gibco Laboratories Life Technologies, Inc. | Apr 29, 1987 | SESE |
| K864253 | THAYER MARTIN AGAR | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K864252 | THAYER-MARTIN JEMBEC | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K864803 | GC-LECT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 3, 1987 | SESE |
| K864078 | MODIFIED N.Y.C. FERMENTATION MEDIUM BASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 31, 1986 | SESE |
| K860384 | BIOTIS MODIFIED THAYER MARTIN | Otisville Biotech, Inc. | Feb 24, 1986 | SESE |
| K854275 | THAYER-MARTIN MEDIUM (MOD) | R. Kent Richards, Inc. | Nov 12, 1985 | SESE |
| K853237 | APL MARTIN LEWIS MEDIUM | Apl Medical Supplies | Aug 19, 1985 | SESE |
| K851579 | CHOCOLATE MUELLER HINTON AGAR | Preferred Micro-Media | May 8, 1985 | SESE |
Top Applicants
- Granite Diagnostics, Inc. — 6 clearances
- Gibco Laboratories Life Technologies, Inc. — 5 clearances
- Isle Media and Sterile Products, Inc. — 5 clearances
- Otisville Biotech, Inc. — 5 clearances
- Flow Laboratories, Inc. — 4 clearances
