INFLUENZA B ANITGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

INFLUENZA A ANTIGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

RSV ANTIGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

CMV EARLY ANTIGEN TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Scimedx IFA Human Cytomegalovirus (HCMV) IgG Assay

FDA registration

SCIMEDX CORP.·1 product·🇺🇸 United States

Hemagen Cytomegalovirus (CMV) IgM Kit

FDA registration

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

ZEUS SCIENTIFIC

FDA registration

ZEUS SCIENTIFIC·1 product·🇺🇸 United States

ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS

FDA registration

ZEUS SCIENTIFIC·1 product·🇺🇸 United States

BION Cytomegalovirus, IgG, Test System

FDA registration

PHADIA US INC.·1 product·🇺🇸 United States

CMV

FDA registration

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

Test System

FDA registration

BION ENTERPRISES, LTD.·1 product·🇺🇸 United States

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM

Tinaquant Ferritin Gen4

FDA UDI

Roche Diagnostics GmbH·04015630925308·

ACE

FDA UDI

ALFA WASSERMANN, INC.·00857969006167·Ferritin Application Kit

Reagent

FDA UDI

Chromsystems Instruments + Chemicals GmbH·04250317500465·Mobile Phase, VMA, HVA, 5-HIAA in urine

FERR

FDA UDI

RANDOX LABORATORIES LIMITED·05055273203073·This product is intended for the quantitative i...

Alinity

FDA UDI

ABBOTT IRELAND·00380740131487·Alinity i Ferritin Reagent Kit 1200 Tests

Reagent

FDA UDI

Chromsystems Instruments + Chemicals GmbH·04250317543240·Potential Optimisation Mix, VMA, HVA, 5-HIAA in...

Reagent

FDA UDI

Chromsystems Instruments + Chemicals GmbH·04250317500335·Wash Buffer II, VMA, HVA, 5-HIAA in urine, Prep...

VMA-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042682238·ETHYL ACETATE,1.2L