Antisera, All Groups, N. Meningitidis
FDA product code GTJ · Class II (moderate risk) · 21 CFR 866.3390 · Microbiology
16510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952791 | Directigen Meningitis Combo TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/30/1996SE |
| K915330 | Directigen Meningitis Combo Test KitGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/23/1992SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | Vitek Systems, Inc. | 08/12/1991SE |
| K885004 | Bactigen(R) N. MeningitidisGTJ · Traditional | Armkel, LLC | 02/07/1989SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | Microscan Div. Baxter Healthcare Corp. | 03/17/1987SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K844999 | Phadebact CSF TestGTJ · Traditional | Pharmacia, Inc. | 10/17/1985SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | Wellcome Diagnostics | 06/10/1985SE |
| K844762 | Meningococcus Group B Monoclonal Antibody ZM-51GTJ · Traditional | Wellcome Diagnostics | 06/04/1985SE |
| K844407 | Directigen Neissena Menningitidis Group B TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/25/1985SE |
| K841907 | Bactigen - N.Menninigitidis TestGTJ · Traditional | Armkel, LLC | 07/06/1984SE |
| K833063 | Wellcogen N. Meningitidis A,C,Y W135GTJ · Traditional | Wellcome Diagnostics | 01/10/1984SE |
| K823880 | Bactigen-N. MeningitidisGTJ · Traditional | Armkel, LLC | 03/09/1983SE |
| K822810 | Phadebact CSF Test 20GTJ · Traditional | Pharmacia, Inc. | 12/30/1982SE |
| K771562 | Agglutinating Serum W135GTJ · Traditional | Burroughs Wellcome Co. | 08/25/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2927-2026 Class II | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901…Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not… | Remel Europe Ltd. | 07/17/2026Open, Classified |
| Z-1562-2008 | BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135 | BD Diagnostic Systems / Lee Laboratories | 09/06/2007Terminated |
| Z-1561-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135 | BD Diagnostic Systems / Lee Laboratories | 09/06/2007Terminated |
| Z-1560-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135. | BD Diagnostic Systems / Lee Laboratories | 09/06/2007Terminated |
| Z-1559-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135. | BD Diagnostic Systems / Lee Laboratories | 09/06/2007Terminated |