8,660 results
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48ms
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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.