1,056 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
FDA 510(k)
FDA Class 2
·Microbiology
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
FDA 510(k)
FDA Class 2
·Microbiology
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
BioFire COVID-19 Test 2
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
FDA 510(k)
FDA Class 2
·Microbiology
BioFire COVID-19 Test 2
FDA 510(k)
FDA Class 2
·Microbiology
Aptima SARS-CoV-2 Assay
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa COVID-19 Direct
FDA 510(k)
FDA Class 2
·Microbiology
HIVOX SPOPAD EMS
FDA 510(k)
FDA Class 2
·Physical Medicine
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
FDA 510(k)
FDA Class 2
·General Hospital
LED Curing Light GT-2000
FDA 510(k)
FDA Class 2
·Dental
EM25 - glute toning device
FDA 510(k)
FDA Class 2
·Physical Medicine
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LED CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
LED Curing Light
FDA 510(k)
FDA Class 2
·Dental
BLUELEX
FDA 510(k)
FDA Class 2
·Dental
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
FDA 510(k)
FDA Class 2
·General Hospital