REPLIANALYZER

FDA 510(k)

FDA Class 2 ·Microbiology

MUELLER HINTON AGARS

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA H FACTOR 5 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

OPUS CMV-G

FDA 510(k)

FDA Class 2 ·Microbiology

INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

FDA 510(k)

FDA Class 2 ·Microbiology

SALMONELLA O GROUPING ANTISERA SET

FDA 510(k)

FDA Class 2 ·Microbiology

Accula RSV Test

FDA 510(k)

FDA Class 2 ·Microbiology

ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CRAG LATERAL FLOW ASSAY (LFA)

FDA 510(k)

FDA Class 2 ·Microbiology

VRESELECT CULTURE MEDIUM

FDA 510(k)

FDA Class 2 ·Microbiology

BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

BBL GASPAK POUCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HERPESELECT 1 ELISA IGG, MODEL EL0910G

FDA 510(k)

FDA Class 2 ·Microbiology

CHOLERA SMART(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

VZVSCAN(TM) LATEX AGGUTINATION TEST

FDA 510(k)

FDA Class 2 ·Microbiology

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

FDA 510(k)

FDA Class 2 ·Microbiology