Antisera, All Types, H. Influenza
FDA product code GRP · Class II (moderate risk) · 21 CFR 866.3300 · Microbiology
6510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884967 | Bactigen(R) H. Influenzae Type BGRP · Traditional | Armkel, LLC | 02/07/1989SE |
| K854490 | Immunoscan Direct Hemophilus Influenzae Type B TesGRP · Traditional | American Micro Scan | 12/27/1985SE |
| K831525 | H-Flu B Elisa TestGRP · Traditional | Seragen Diagnostics, Inc. | 09/29/1983SE |
| K823348 | H. Influenza B Antisera for CieGRP · Traditional | Diagnostica, Inc. | 12/28/1982SE |
| K821266 | BBL Directigen Meningitis Test KitGRP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/01/1982SE |
| K820192 | Haemophilus Influenzae Type B AntiserumGRP · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 03/11/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1469-2020 Class II | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro…A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of… | The Binding Site Group, Ltd. | 08/12/2018Terminated |