10,000 results · 46ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

U-Catch

FDA UDI
Shenzhen Bioeasy Biotechnology Co., Ltd·06972428161776·

Rapid Response

FDA UDI
BTNX Inc·00722066004647·One Step 5 Panel DOA Cup (5.2) - COC300 AMP1000...

Total Prostate Specific Antigen(CLIA)、Total PSA Calibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

BAUMER PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

BAUMER PINS

FDA 510(k)
FDA Class 2 ·Orthopedic

BAUMER STAPLES

FDA 510(k)
FDA Class 2 ·Orthopedic

INTRAMEDULLARY SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

BAUMER SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

Test, Phencyclidine (Pcp), Over The Counter

FDA classification
FDA Unclassified ·Test, Phencyclidine (Pcp), Over The Counter

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Device
EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Device
EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Device
EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Device
EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries

ACRO Multi-Drug Rapid Urine Test Cup (prescription & CLIA WAIVED)

FDA registration
ACRO BIOTECH Inc.·10 products·🇺🇸 United States

Atida Multiplex Drug of Abuse Urine Dip Card Test

FDA registration
ACESO LABORATORIES INC.·10 products·🇺🇸 United States

PocguideTM Multi-Drug Test Panel OTC

FDA registration
AICHECK BIOTECH, INC·10 products·🇺🇸 United States

AllTest Multi-Drug Urine Test Cup

FDA registration
Hangzhou AllTest Biotech Co.,Ltd·10 products·🇨🇳 China

Rapid Response Drug Screen Panel

FDA registration
BTNX Inc.·10 products·🇨🇦 Canada