131 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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INNOFLOUR CALIBRATOR REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMX HOMOCYSTEINE
FDA 510(k)
FDA Class 2
·Immunology
INNOFLUOR QUINIDINE ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO IMX HOMOCYSTEINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INNOFLUOR PHENYTOIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INNOFLUOR GENTAMICIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AFINION ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
FDA 510(k)
FDA Class 2
·Immunology
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
AFINION HBALC
FDA 510(k)
FDA Class 2
·Hematology
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
FDA 510(k)
FDA Class 2
·Immunology
Axis Spine Technologies ALIF
FDA 510(k)
FDA Class 2
·Orthopedic
AXIS-SHIELD ACVTIVE-B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry