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Microbiology devices
418 product codes reviewed by the Microbiology panel. 6,965 510(k) clearances and 1,455 recalls in the FDA data, 54% of those recalls name a 510(k).
97510(k)s in 12 months
68recalls in 12 months
786recalls that name a 510(k)
Active product codes, Class I
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 2 | 4 |
| JTR | Kit, Quality Control For Culture Media | 1 | 0 | 4 |
| LSE | Epstein-Barr Virus, Other | 1 | 2 | 1 |
| KZJ | Device, Gas Generating | 1 | 0 | 2 |
| LYR | Helicobacter Pylori | 1 | 0 | 2 |
| GPN | Antiserum, Typhus Fever | 1 | 0 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 | 0 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 0 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 | 0 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 0 | 1 |
| JTQ | Bath, Incubators/Water, All | 1 | 0 | 1 |
| JWZ | Kit, Screening, Trichomonas | 1 | 0 | 1 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | 0 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 0 | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 | 0 |
| LQG | Dna-Reagents, Mycoplasma Spp. | 1 | 0 | 1 |
| LQL | Gram Positive Identification Panel | 1 | 0 | 1 |
| MDB | System, Blood Culturing | 1 | 1 | 0 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | 0 | 1 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | 0 | 1 |
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