BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology

CULTURE TEST FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

AMIKACIN REAGENT TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FLUORESCEIN CONJUGATED IMMUNOGLOBIN-

FDA 510(k)

FDA Class 2 ·Immunology

WAKO(TM) IGG-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

LEPTOSPIROSIS IHA

FDA 510(k)

FDA Class 2 ·Microbiology

INCSTAR'S PIGWEED ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ELISA-DOXA COMBI-6

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGD IMMUNOLOGICAL NL TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PASCO MIC AND MIC/ID PANELS (OFLOXACIN)

FDA 510(k)

FDA Class 2 ·Microbiology

HardyDisk AST Omadacycline 30µg (OMC30)

FDA 510(k)

FDA Class 2 ·Microbiology

ROMA Calculation Tool Using Elecsys Assays

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

THE GOLDEN QUAD TEST (HSV)

FDA 510(k)

FDA Class 2 ·Microbiology

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

cobas vivoDx MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

DRIED GRAM-NEGATIVE MIC//COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology