8,375 results
·
38ms
·
Sources: EU EUDAMED, US FDA
XN CAL
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SYSMEX CORPORATION·1 device
Syneture
FDA UDI
Covidien LP·10884521742635·Custom Suture Pack, (4) 88862914-51, (2) CL-64-...
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
FDA 510(k)
FDA Class 2
·Hematology
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM
ONE‐CAL 2
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.·1 device
XN CAL PF
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SYSMEX CORPORATION·1 device
sthemO Heparin cal
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Diagnostica Stago·1 device
sthemO FDP cal
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
348 Cal-Pack
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Diamond Diagnostics Inc·1 device
sthemO VWF cal
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
Cal-P Calibrator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Zybio Inc.·2 devices
Cal-Pack 644
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Przedsiębiorstwo Produkcji i Handlu MEDRIV sp. z o.o.·1 device
S-CAL Calibrator
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC
FDA 510(k)
FDA Class 2
·Immunology
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry