GTJ · Antisera, All Groups, N. Meningitidis
Microbiology · 21 CFR 866.3390 · Class 2
Overview
| Product Code | GTJ |
|---|---|
| Device Name | Antisera, All Groups, N. Meningitidis |
| Regulation | 21 CFR 866.3390 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952791 | DIRECTIGEN MENINGITIS COMBO TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 30, 1996 | SESE |
| K915330 | DIRECTIGEN MENINGITIS COMBO TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 23, 1992 | SESE |
| K910210 | SLIDEX MENINGITE-KIT 5 | Vitek Systems, Inc. | Aug 12, 1991 | SESE |
| K885004 | BACTIGEN(R) N. MENINGITIDIS | Armkel, LLC | Feb 7, 1989 | SESE |
| K870089 | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT | Microscan Div. Baxter Healthcare Corp. | Mar 17, 1987 | SESE |
| K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT | Wellcome Diagnostics | Feb 4, 1986 | SESE |
| K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 | Wellcome Diagnostics | Feb 4, 1986 | SESE |
| K844999 | PHADEBACT CSF TEST | Pharmacia, Inc. | Oct 17, 1985 | SESE |
| K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 | Wellcome Diagnostics | Jun 10, 1985 | SESE |
| K844762 | MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 | Wellcome Diagnostics | Jun 4, 1985 | SESE |
| K844407 | DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 25, 1985 | SESE |
| K841907 | BACTIGEN - N.MENNINIGITIDIS TEST | Armkel, LLC | Jul 6, 1984 | SESE |
| K833063 | WELLCOGEN N. MENINGITIDIS A,C,Y W135 | Wellcome Diagnostics | Jan 10, 1984 | SESE |
| K823880 | BACTIGEN-N. MENINGITIDIS | Armkel, LLC | Mar 9, 1983 | SESE |
| K822810 | PHADEBACT CSF TEST 20 | Pharmacia, Inc. | Dec 30, 1982 | SESE |
| K771562 | AGGLUTINATING SERUM W135 | Burroughs Wellcome Co. | Aug 25, 1977 | SESE |
Top Applicants
- Wellcome Diagnostics — 5 clearances
- Armkel, LLC — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- Pharmacia, Inc. — 2 clearances
- Burroughs Wellcome Co. — 1 clearance
