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