FIAPresto FIAVet

Bifour Biotech Inc. · US-MF-000034957

Wariant (UDI-DI)
UDI-DI00860010246207
Secondary DI
Nr katalogowyFIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
Status rynkowyNa rynku UE
Pierwsze wprowadzenieAustria
Wersja EUDAMED1
Rodzaj (EMDN)IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES; IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES; IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES; IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › IMMUNOCHEMISTRY INSTRUMENTS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS › AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
Kody EMDNW0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
W0201020192 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
Wyrób (Basic UDI-DI)
Basic UDI-DI08600102462BBIITRI001AN
Nazwa wyrobuTime-resolved immunofluorescence analyzer
ModelFIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
Klasa ryzykaKlasa A
Podstawa prawnaIVDR
Typanalizator
Użytek profesjonalnytak
Dane dodatkowe

Brak Danych dodatkowych – dane z backendu interfejsu EUDAMED nie zostały jeszcze pobrane.