BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

Plasmodium Spp. Detection Reagents

FDA classification

FDA Class 2 ·Plasmodium Spp. Detection Reagents

CHORUS POLIOVIRUS IgG

FDA registration

DIESSE DIAGNOSTICA SENESE S.P.A·1 product·🇮🇹 Italy

Rapid Response Rotavirus Test Cassettes (Direct Ag/Visual)

FDA registration

BTNX Inc.·1 product·🇨🇦 Canada

OnSite Rotavirus Ag Rapid Test (REF# R0194C)

FDA registration

CTK BIOTECH, INC.·1 product·🇺🇸 United States

D3 IFA-DFA Enterovirus

FDA registration

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

Vstrip

FDA registration

Panion & BF Biotech Inc. Xizhi Second Factory·1 product·🇹🇼 Taiwan

750030 ImmunoCard STAT! Rotavirus

FDA registration

MERIDIAN BIOSCIENCE, INC.·1 product·🇺🇸 United States

ProSpecT Rotavirus

FDA registration

REMEL EUROPE LTD·1 product·🇬🇧 United Kingdom

IMAGEN PARAINFLUENZA GROUP

FDA registration

OXOID, LTD.·1 product·🇬🇧 United Kingdom

Rotavirus

FDA registration

IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States

DEMEDITEC DIAGNOSTICS GmbH

FDA registration

DEMEDITEC DIAGNOSTICS GmbH·1 product·🇩🇪 Germany

Influenza A&B

FDA registration

HANGZHOU ROLLMED CO.,LTD.·1 product·🇨🇳 China

??

FDA registration

REMEL EUROPE LTD·1 product·🇬🇧 United Kingdom

LUMIQUICK DIAGNOSTICS, INC.

FDA registration

LUMIQUICK DIAGNOSTICS, INC.·1 product·🇺🇸 United States

Rotavirus antigen rapid test

FDA registration

Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

IMAGEN PARAINFLUENZA GROUP

FDA registration

REMEL EUROPE LTD·1 product·🇬🇧 United Kingdom

Rotavirus & Adenovirus Combo Test

FDA registration

ACESO LABORATORIES INC.·1 product·🇺🇸 United States

BioDigit, Rotavirus, Enzyme Linked Immunoabsorbent Assay, Rotavirus

FDA registration

STS CORPORATION·1 product·🇺🇸 United States

Sekisui Diagnostics, LLC

FDA registration

Sekisui Diagnostics, LLC·1 product·🇺🇸 United States