Branchburg, NJ, US · 8 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | Class II | Immunology | 2 | 2026-08-21 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Class II | Immunology | 2 | 2025-10-22 |
| OBE | Anti-Ss-A 52 Autoantibodies | Class II | Immunology | 1 | 2026-05-08 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | Class II | Immunology | 1 | 2023-08-31 |
| LSR | Reagent, Borrelia Serological Reagent | Class II | Microbiology | 1 | 2023-07-13 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Class II | Immunology | 1 | 2022-04-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-10-31 | Class II | Ongoing | Z-0603-2024 | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G | — | The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved … |
| 2023-10-31 | Class II | Ongoing | Z-0602-2024 | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M | — | The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-21 | K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | MOB | Class II | Immunology |
| 2026-05-08 | K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | OBE | Class II | Immunology |
| 2025-10-22 | K250666 | Alegria Flash CTD Screen | LLL | Class II | Immunology |
| 2025-09-19 | K250408 | Alegria Flash ENA Screen | LLL | Class II | Immunology |
| 2025-05-07 | K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | MOB | Class II | Immunology |
| 2023-08-31 | K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | KTL | Class II | Immunology |
| 2023-07-13 | K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | LSR | Class II | Microbiology |
| 2022-04-29 | K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | DHN | Class II | Immunology |