dIFine M1 with camera
2025-07-31
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3026753391 | 3026753391 | VISIA LAB SRL | 1 | N | 2026-01-01 | VIA MARTIRI DELLA LIBERTA 95/D SAN GIOVANNI VALDARNO Arezzo IT 52027 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 307562 | 1748519368 | K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | MOB | 2025-05-07 |
| 307562 | 1178259354 | K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | KTL | 2023-08-31 |
| 307562 | 1127642203 | K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | DHN | 2022-04-29 |
| 307562 | 1928846068 | ||||
| 307562 | 1986641308 |
2025-07-31
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