198 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Adaptive Biotechnologies clonoSEQ Assay
FDA 510(k)
FDA Class 2
·Pathology
VENTANA CD30 (Ber-H2) RxDx Assay
FDA 510(k)
FDA Class 2
·Immunology
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
FDA 510(k)
FDA Class 2
·Immunology
Parsortix PC1 Device
FDA 510(k)
FDA Class 2
·Immunology
GenetiSure Dx Postnatal Assay
FDA 510(k)
FDA Class 2
·Immunology
xTAG Cystic Fibrosis 39 Kit v2
FDA 510(k)
FDA Class 2
·Immunology
MTS Doxycycline 0.016 - 256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS Gentamicin 0.016 - 256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS Omadacycline 0.002 - 32 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
ComASP Cefiderocol 0.008-128
FDA 510(k)
FDA Class 2
·Microbiology
MTS Ciprofloxacin 0.002 - 32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS Eravacycline 0.002 - 32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS Penicillin 0.002- 32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology