765 results · 84ms · Sources: EU EUDAMED, US FDA

ARCHITECT ROMA (LN 6P30-21)

FDA registration
ABBOTT LABORATORIES·1 product·🇺🇸 United States

Overa

FDA registration
Aspira Women's Health, Inc.·1 product·🇺🇸 United States

ROMA (HE4 EIA + ARCHITECT CA 125 II)

FDA registration
Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

ARCHITECT ROMA

FDA registration
Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

OVA 1 Test

FDA registration
Aspira Women's Health, Inc.·1 product·🇺🇸 United States

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740138738·ARCHITECT ROMA

Lumipulse G ROMA

FDA UDI
Fujirebio Diagnostics, Inc.·00869164000017·Software Disk

Alinity

FDA UDI
Abbott GmbH·00380740146269·Alinity i ROMA

ROMA Calculation Tool Using Elecsys Assay

FDA UDI
Roche Diagnostics GmbH·00365702702127·

Overa

FDA UDI
Aspira Women's Health Inc.·00860942000106·The Overa® test is a qualitative serum test tha...

ROMA

FDA UDI
Fujirebio Diagnostics, Inc.·00869164000024·ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

OVA1

FDA UDI
Aspira Women's Health Inc.·00860942000113·Ova1® is a qualitative serum test that combines...

ARCHITECT ROMA

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OVA1 Next Generation

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OVA1 TEST

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ROMA (HE4 EIA + ARCHITECT CA 125 II)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Lumipulse G ROMA

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ROMA Calculation Tool Using Elecsys Assays

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Ovarian Adnexal Mass Assessment Score Test System

FDA classification
FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

Access BR Monitor

FDA registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI·2 products·🇹🇷 Türkiye