PLUG 'N VIEW 3D, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

VOXAR 3D ENTERPRISE WITH CARDIAMETRIX

FDA 510(k)

FDA Class 2 ·Radiology

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DIASTAT ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ENA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay)

Device

EU IVDD · Eu Ivd General ·Wuhan Life Origin Biotech Joint Stock Co., Ltd.·On the market·32 countries

B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay)

Device

EU IVDD · Eu Ivd General ·Wuhan Life Origin Biotech Joint Stock Co., Ltd.·On the market·32 countries

B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay)

Device

EU IVDD · Eu Ivd General ·Wuhan Life Origin Biotech Joint Stock Co., Ltd.·On the market·32 countries

Diagnostic Kit for BNP (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·On the market

BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·Jiangsu Accuracy Biotechnology Co.,Ltd.·On the market

BIOPLEX 2200 MULTI-AN

FDA registration

Bio-Rad Laboratories, Inc.·6 products·🇺🇸 United States

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP

VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158

FDA 510(k)

FDA Class 2 ·Clinical Chemistry