8,660 results · 48ms · Sources: EU EUDAMED, US FDA

Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

FDA 510(k)
FDA Class 2 ·Hematology

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Regulatory Quality Management Information Source AREU, S.L.U

Authorized representative
🇪🇸 Spain·8 Manufacturers·51 Devices

BR60 Hematology Control,SC-CAL RET Hematology Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·14 devices

i-STAT

FDA UDI
ABBOTT POINT OF CARE INC.·10054749001917·CARTRIDGE, CHEM8+

ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EVO DOCKING STATION USB CONN & EU PWR CBL

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Spacelabs Healthcare Ltd·1 device

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Piccolo Basic Metabolic Panel

FDA UDI
ABAXIS, INC.·EABA40000241·The Piccolo® Basic Metabolic Panel, used with t...

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Randox Laboratories Limited·1 device

i-STAT

FDA UDI
ABBOTT POINT OF CARE INC.·10054749000071·EC8+ CARTRIDGE

Piccolo MetLyte 8 Panel

FDA UDI
ABAXIS, INC.·EABA40000231·The Piccolo® MetLyte 8 Panel, used with the Pic...

Computer, Oxygen-Uptake

FDA classification
FDA Class 2 ·Computer, Oxygen-Uptake

Laryngoscope, Non-Rigid

FDA classification
FDA Class 1 ·Laryngoscope, Non-Rigid

Metaphor Flow Sensor

FDA UDI
TREYMED INC·B23133141·Neonate flow sensor. Pack of 10.