Antisera, All Groups, N. Meningitidis
The Antisera, All Groups, N. Meningitidis is a collection of antisera covering all serogroups of Neisseria meningitidis, used in laboratory agglutination tests for serogrouping meningococcal isolates, which is critical for public health outbreak investigations. It is an FDA Class 2 device requiring 510(k) premarket notification to demonstrate moderate-risk compliance. Regulated under 21 CFR 866.3390 with product code GTJ in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GTJ
- Device Class
- FDA class 2
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952791 | DIRECTIGEN MENINGITIS COMBO TEST | May 30, 1996 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K915330 | DIRECTIGEN MENINGITIS COMBO TEST KIT | Mar 23, 1992 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K910210 | SLIDEX MENINGITE-KIT 5 | Aug 12, 1991 | Substantially Equivalent | Vitek Systems, Inc. |
| K885004 | BACTIGEN(R) N. MENINGITIDIS | Feb 07, 1989 | Substantially Equivalent | Armkel, LLC |
| K870089 | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT | Mar 17, 1987 | Substantially Equivalent | Microscan Div. Baxter Healthcare Corp. |
| K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT | Feb 04, 1986 | Substantially Equivalent | Wellcome Diagnostics |
| K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 | Feb 04, 1986 | Substantially Equivalent | Wellcome Diagnostics |
| K844999 | PHADEBACT CSF TEST | Oct 17, 1985 | Substantially Equivalent | Pharmacia, Inc. |
| K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 | Jun 10, 1985 | Substantially Equivalent | Wellcome Diagnostics |
| K844762 | MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 | Jun 04, 1985 | Substantially Equivalent | Wellcome Diagnostics |
| K844407 | DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST | Jan 25, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K841907 | BACTIGEN - N.MENNINIGITIDIS TEST | Jul 06, 1984 | Substantially Equivalent | Armkel, LLC |
| K833063 | WELLCOGEN N. MENINGITIDIS A,C,Y W135 | Jan 10, 1984 | Substantially Equivalent | Wellcome Diagnostics |
| K823880 | BACTIGEN-N. MENINGITIDIS | Mar 09, 1983 | Substantially Equivalent | Armkel, LLC |
| K822810 | PHADEBACT CSF TEST 20 | Dec 30, 1982 | Substantially Equivalent | Pharmacia, Inc. |
| K771562 | AGGLUTINATING SERUM W135 | Aug 25, 1977 | Substantially Equivalent | Burroughs Wellcome Co. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.