32 results · 18ms · Sources: EU EUDAMED, US FDA

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FOVS, BRILLARTE, ETC...

FDA 510(k)
FDA Class 1 ·Ophthalmic

Elecsys Anti-SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

Aptima SARS-CoV-2 Assay

FDA 510(k)
FDA Class 2 ·Microbiology

Elecsys Anti-SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus

FDA 510(k)
FDA Class 2 ·Microbiology

Elecsys Anti-SARS-CoV-2 S

FDA 510(k)
FDA Class 2 ·Microbiology

FINDER Flu A&B/SARS-CoV-2 Test

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

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

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

FDA 510(k)
FDA Class 2 ·Microbiology

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

FDA 510(k)
FDA Class 2 ·Microbiology

THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV

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

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)
FDA Class 2 ·Microbiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

FDA 510(k)
FDA Class 2 ·Microbiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)
FDA Class 2 ·Microbiology