REVISED LABELING FOR METHAQUALONE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FebriDx Bacterial / Non-bacterial Point of Care Assay

FDA 510(k)

FDA Class 2 ·Microbiology

ARTUS C. DIFFICILE QS-RGQ MDX KIT

FDA 510(k)

FDA Class 2 ·Microbiology

EMIT ST URINE METHAGUALONE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

Radioimmunoassay, Methaqualone

FDA classification

FDA Class 2 ·Radioimmunoassay, Methaqualone

Test, Methaqualone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methaqualone, Employment And Insurance Testing, Exempt

Rapid Response

FDA UDI

BTNX Inc·10722066006617·Rapid Response 5 Panel Saliva Test Cup E/I Scre...

Rapid Response

FDA UDI

BTNX Inc·10722066006624·Rapid Response 10 Panel Saliva Test Cup E/I Scr...

COBAS INTEGRA REAGENT CASSETTES

FDA registration

ROCHE DIAGNOSTICS GMBH·27 products·🇩🇪 Germany

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany

Analyzer

FDA registration

Diamond Diagnostics Inc.·78 products·🇭🇺 Hungary

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·78 products·🇨🇭 Switzerland