ePlex® Respiratory Pathogen (RP) Panel

FDA registration

HOCHUEN MEDICAL SDN. BHD.·10 products·🇲🇾 Malaysia

ePlex® Respiratory Pathogen (RP) Panel

FDA registration

Hochuen Medical Technology Co.,Ltd.·10 products·🇨🇳 China

Chemistry Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·ROBERT RIELE GmbH & Co KG·1 device

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714002960·Serum Diluent

Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 MULTI-AN

FDA registration

Bio-Rad Laboratories, Inc.·6 products·🇺🇸 United States

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

FDA 510(k)

FDA Class 2 ·General Hospital

H-FLOW VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BACSTOP

FDA 510(k)

FDA Class 2 ·General Hospital

DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

FDA 510(k)

FDA Class 2 ·General Hospital

SAFEPORT MANIFOLD (TM) (OR STOPCOCK)

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXI-Q DV AND DVR AUTO-INJECTORS

FDA 510(k)

FDA Class 2 ·General Hospital

Y-CLICK CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK

FDA 510(k)

FDA Class 2 ·General Hospital