ALL SILICONE THORA

FDA registration

FORTUNE MEDICAL INSTRUMENT CORP.·1 product·🇹🇼 Taiwan

VIAMED VENTRICULAR CATHETER

FDA registration

RECE INTERNATIONAL CORP.·1 product·🇺🇸 United States

Thoracic Catheters

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

JD-HOOK Safety Stylet Accessory

FDA registration

Hangzhou Fushan Medical Appliance Co., Ltd.·1 product·🇨🇳 China

NOVO VIVO SUCTON CATHETER

FDA registration

GENESIS INDUSTRIES, INC.·1 product·🇺🇸 United States

Xpert GBS LB

FDA UDI

CEPHEID·07332940000806·Xpert GBS LB kit; 120 test kit

Xpert GBS LB

FDA UDI

CEPHEID·07332940000882·Xpert GBS LB kit; 10 test kit

CE VRE-03 VRE Positive (Van B)

FDA registration

Microbiologics, Inc.·1 product·🇺🇸 United States

Revogene GBS LB

FDA UDI

MERIDIAN BIOSCIENCE, INC.·00840733102363·The Revogene GBS LB assay performed on the Revo...

EasyNAT GBS Assay

Device

EU IVDR · Eu Ivd Class C ·Ustar Biotechnologies (Hangzhou) Ltd.·On the market·2 countries

GBS Screen Broth

Device

EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·On the market

GBS Screen Broth

Device

EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·On the market

BIOSYNEX AMPLIFLASH GBS

Device

EU IVDR · Eu Ivd Class C ·BIOSYNEX·No longer on the market·1 country

Inocu Swabs

FDA UDI

MICROBIOLOGICS INC.·10634853001272·Group B Strep Negative

Inocu Swabs

FDA UDI

MICROBIOLOGICS INC.·10634853001265·Group B Strep Positive

N/A

FDA UDI

HARDY DIAGNOSTICS·00816576028023·GBS Detect™, 15x100mm Plate, 17ml (reduced stac...

SmartCycler Dx System

FDA UDI

CEPHEID·07332940004835·SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE...

SmartCycler Dx System

FDA UDI

CEPHEID·07332940004767·SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE...

SmartCycler Dx System

FDA UDI

CEPHEID·07332940004880·SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE...

SmartCycler Dx System

FDA UDI

CEPHEID·07332940004798·SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE...