System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

Luteinizing Hormone（CLIA）、LH Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Regional Anesthesia Kit

FDA classification

FDA Class 2 ·Regional Anesthesia Kit

Test, Benzodiazepine, Over The Counter

FDA classification

FDA Class 2 ·Test, Benzodiazepine, Over The Counter

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405023868·5 Panel CLIA Waived Click Cup BUP10, BZO300, C...

Rapid Response

FDA UDI

BTNX Inc·10722066005313·Rapid Response Multi Drug Test Panels (AMP/EDDP...

T-Dip

FDA UDI

WONDFO USA CO., LTD.·00816862023657·6-Panel Card without THC; BUP,BZO,COC,MOP,MTD,OXY

Rapid Response

FDA UDI

BTNX Inc·00722066004791·7-Drug Test Panel - 25/Kit (7.17) - COC300 MET1...

Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Safecare Multi-Drug Urine Test Cup

FDA registration

SAFECARE BIOTECH(HANGZHOU)CO.,LTD·8 products·🇨🇳 China

CLUNGENE® Multi-Drug Test Dip Card

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·8 products·🇨🇳 China

Accutest

FDA UDI

JANT PHARMACAL CORPORATION·10763924093639·Drug Test Cup 5 for visual qualitative detectio...

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405023332·7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, ...

Healgen (Private Label) - 654

FDA UDI

CONFIRM BIOSCIENCES, INC.·00895330002646·Healgen (DrugConfirm) - 5 Panel Dip Card - CLIA...

Rapid Response

FDA UDI

BTNX Inc·00722066004814·Rapid Response Multi Drug Test Panel

UScreen®

FDA UDI

Instant Technologies, Inc.·00817405021239·U-Screen Squared Integrated CLIA Waived Cup 7 P...

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405023264·7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, ...

Prime Screen

FDA UDI

WONDFO USA CO., LTD.·00816862023671·5-Panel Card; 5 per box; AMP,BZO,COC,OPI,THC