DENV Detect NS1 ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

Dengue Virus Antigen Assay

FDA classification

FDA Class 2 ·Dengue Virus Antigen Assay

ACU 1060.1

FDA registration

INSTRUMENTATION INDUSTRIES, INCORPORATED·1 product·🇺🇸 United States

ICU Medical, Inc.

Manufacturer

🇺🇸 United States·1 Importer

ICU Medical, Inc.

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·55 Devices·1 Importer

FCU Co., Ltd.

Manufacturer

🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

ACU-MICRO-NEEDLE

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

ACU-PUNCH

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

ICU Medical Australia Pty Limited

Manufacturer

🇦🇺 Australia

Acu Loc 2 System

FDA registration

ACUMED LLC·2 products·🇺🇸 United States

Acu-Strap Motion Sickness Band: Acu-Life, EzyDose, Flents; 400198, HK400198

FDA registration

APOTHECARY PRODUCTS, LLC.·1 product·🇺🇸 United States

KIT SPANISH 560P HIGH DEF CCU

FDA registration

SMITH & NEPHEW INC.·1 product·🇺🇸 United States

KIT SPANISH 560P HIGH DEF CCU

FDA registration

SMITH & NEPHEW INC.·1 product·🇺🇸 United States

Acu-Punch

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

ACU-EVAC

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

GI CCU

FDA registration

KARL STORZ SE & CO. KG·1 product·🇩🇪 Germany

GI CCU

FDA registration

KARL STORZ SE & CO KG·1 product·🇩🇪 Germany

GI CCU

FDA registration

KARL STORZ IMAGING, INC.·1 product·🇺🇸 United States

Acu-Flow™

FDA registration

DEN-MAT HOLDINGS, LLC·1 product·🇺🇸 United States

GI CCU

FDA registration

Karl Storz Endoscopy-America, Inc.·1 product·🇺🇸 United States