10,000 results · 51ms · Sources: EU EUDAMED, US FDA

StatusFirst™ 5/MET card

FDA UDI
PRINCETON BIOMEDITECH CORPORATION·10743816000396·StatusFirst™ ME/O(2K)/C/TH/P card; 25 Test kit;...

PAP Stain Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hunan Lituo Biotechnology Co., Ltd.·12 devices

V-PEP/IMT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GH Innotek Co., Ltd.·1 device

Bubble PAP Valve

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GaleMed Corporation·3 devices

Glucose GOD-PAP

Basic UDI-DI
EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Glucose GOD-PAP

Basic UDI-DI
EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Wooden Pap Test

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Medex International Ltd·1 device

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval
FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Yumizen C1200 Immunoglobulin M

FDA registration
HORIBA ABX SAS·4 products·🇫🇷 France

446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent

FDA registration
BECKMAN COULTER, INC.·4 products·🇺🇸 United States

446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent

FDA registration
BECKMAN COULTER, INC.·4 products·🇺🇸 United States

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD PREPSTAIN SYSTEM

PAP/Respiratory Lithium Ion

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Respironics Inc.·9 devices

Phencyclidine (PCP) Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beijing Jinwofu Bioengineering Technology Co., Ltd.·1 device

Double Action IMT/PEP

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GH Innotek Co., Ltd.·5 devices

ST AIA-PACK PAP

Basic UDI-DI
EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·THINPREP (R) IMAGING SYSTEM

Healgen (Private Label) - 3104C

FDA UDI
CONFIRM BIOSCIENCES, INC.·00895330002769·Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP10...

Healgen (Private Label) - 6104

FDA UDI
CONFIRM BIOSCIENCES, INC.·00856464008386·Healgen (DrugConfirm) - 10 Panel Cup Test: AMP1...

Healgen (Private Label) - 194

FDA UDI
CONFIRM BIOSCIENCES, INC.·00895330002608·Healgen (DrugConfirm) - 9 Panel Dip Card - AMP1...