M7 PEM(FDA,PEM-21,For UMT-200)

FDA UDI

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089768·

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBeAg and PreciControl HBeAg

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon (IGB) System, Endoline Punc

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

ARCHITECT

FDA UDI

Abbott GmbH·00380740017385·ARCHITECT SHBG Calibrators

FastPack® IP SHBG

FDA UDI

QUALIGEN INC.·10816467020348·60 Test SHBG Immunoassay Complete Kit w/Calibra...

Testosterone Luminescence Immunoassay

FDA UDI

IBL International GmbH·04049325003545·Testosterone Luminescence Immunoassay - 96 Det...

ARCHITECT

FDA UDI

Abbott GmbH·00380740003715·ARCHITECT 2nd Generation Testosterone Controls

FastPack® IP SHBG

FDA UDI

QUALIGEN INC.·20816467020345·30 Test SHBG Immunoassay Complete Kit w/Calibra...

ARCHITECT

FDA UDI

Abbott GmbH·00380740003708·ARCHITECT 2nd Generation Testosterone Calibrators

ARCHITECT

FDA UDI

Abbott GmbH·00380740017415·ARCHITECT SHBG Reagent Kit

ARCHITECT

FDA UDI

Abbott GmbH·00380740017392·ARCHITECT SHBG Controls

Testosterone Luminescence Immunoassay

FDA UDI

IBL International GmbH·04049325006546·Testosterone Luminescence Immunoassay - 10 x 9...

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Synergy Ablation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM

BioLyse-FD1 SYS WBC-4-diff reagent 1L

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Bioxol Kft·2 devices

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV II, PreciControl Anti-HCV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck