YO Home Sperm Test

FDA 510(k)

FDA Class 2 ·Hematology

NOVY CORNUAL CANNULATION SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS

FDA 510(k)

FDA Class 2 ·Hematology

LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

SEMEN ANALYSIS KIT

FDA 510(k)

FDA Class 2 ·Hematology

HBA SPERM-HYALURONAN BINDING ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

SPERMCHECK FERTILITY

FDA 510(k)

FDA Class 2 ·Hematology

AUTOMARQER

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Microbiology

DASH® SARS-CoV-2 & Flu A/B Test

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

IDTM SARS-CoV-2/Influenza TriplexIDTM SARS-CoV-2/Influenza Triplex

Device

EU IVDD · Eu Ivd General ·ID SOLUTIONS·On the market

Biomeme SARS-CoV-2 Go-Plates Kit

FDA UDI

Biomeme, Inc.·00810096640086·Pre-aliquoted 96-well PCR plate. Each well cont...

Biomeme SARS-CoV-2 Go-Strips Kit

FDA UDI

Biomeme, Inc.·00810096640048·Pre-aliquoted 3-well PCR strips. Each well cont...

Nano-Check™ COVID-19 Antigen Test

FDA registration

NANO-DITECH CORPORATION·1 product·🇺🇸 United States

ZHEJIANG ORIENT GENE BIOTECH

FDA registration

ZHEJIANG ORIENT GENE BIOTECH·1 product·🇨🇳 China

Sofia 2 SARS Antigen+ FIA

FDA registration

QUIDEL CORP.·1 product·🇺🇸 United States

Sofia 2 SARS Antigen+ FIA

FDA registration

Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

LABORATORIOS SCANTIBODIES S.A. DE C.V.

FDA registration

LABORATORIOS SCANTIBODIES S.A. DE C.V.·1 product·🇲🇽 Mexico