E. COLI 0157 LATEX TEST

FDA 510(k)

FDA Class 1 ·Microbiology

VTEC-RPLA SEIKEN

FDA 510(k)

FDA Class 1 ·Microbiology

Curian® Shiga Toxin

FDA 510(k)

FDA Class 1 ·Microbiology

SHIGA TOXIN QUIK CHEK

FDA 510(k)

FDA Class 1 ·Microbiology

MODIFICATION TO BIOSTAR OIA SHIGATOX

FDA 510(k)

FDA Class 1 ·Microbiology

RIM E.COLI 0157:H7 LATEX TEST

FDA 510(k)

FDA Class 1 ·Microbiology

Antigens, All Types, Escherichia Coli

FDA classification

FDA Class 1 ·Antigens, All Types, Escherichia Coli

Antisera, All Types, Escherichia Coli

FDA classification

FDA Class 1 ·Antisera, All Types, Escherichia Coli

Antisera, Fluorescent, All Types, Escherichia Coli

FDA classification

FDA Class 1 ·Antisera, Fluorescent, All Types, Escherichia Coli

BION ECHOVIRUS ANTI

FDA registration

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

RapidLight PCT CLIA Test (REF# L0400)

FDA registration

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

Elecsys BRAHMS PCT

FDA registration

ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

GNJ / ANTIGENS, HA, ECHOVIRUS 1-34

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

MeMed BV TM

FDA registration

MICROCOAT BIOTECHNOLOGIE GMBH·1 product·🇩🇪 Germany

MeMed BV

FDA registration

MeMed Inc·1 product·🇺🇸 United States

Intellisep Cartridge

FDA registration

Westec Plastics Corporation·1 product·🇺🇸 United States

Diazyme Procalcitonin (PCT) Assay

FDA registration

Diazyme Laboratories, Inc.·1 product·🇺🇸 United States

VITROS BRAHMS PCT Range Verifier

FDA registration

Ortho-Clinical Diagnostics European Support Center·1 product·🇫🇷 France

AbioSCOPE, IVD CAPSULE PSP

FDA registration

ABIONIC SA·1 product·🇨🇭 Switzerland

Cytovale Diluent

FDA registration

Cytovale, Inc. (PBRC)·1 product·🇺🇸 United States