3 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
FDA Enforcement
Class III
·Ongoing·Abbott Molecular, Inc.·March 6, 2024
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
FDA Enforcement
Class III
·Ongoing·Abbott Molecular, Inc.·March 6, 2024
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
FDA Enforcement
Class III
·Ongoing·Abbott Molecular, Inc.·March 6, 2024