Antisera, Fluorescent, All Types, Hemophilus Spp.
FDA product code GRO · Class II (moderate risk) · 21 CFR 866.3300 · Microbiology
4510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851271 | Legionella Culture Confirmatin KitGRO · Traditional | Gen-Probe, Inc. | 07/08/1985SE |
| K834067 | Legionella Differentiation DiskGRO · Traditional | Remel Co. | 01/03/1984SE |
| K802423 | Phadebact Haemophilus TestGRO · Traditional | Pharmacia, Inc. | 11/12/1980SE |
| K800493 | Bactogen-H. Influenzae Type BGRO · Traditional | Armkel, LLC | 04/04/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0523-2013 Class II | BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty…In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives… | Becton Dickinson & Co. | 10/22/2012Terminated |