GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

UNI-GOLD CRYPTOSPORIDIUM

FDA 510(k)

FDA Class 2 ·Microbiology

CELLABS GIARDIA CEL I.F. TEST

FDA 510(k)

FDA Class 2 ·Microbiology

IVD CRYPTO/GIARDIA DFA

FDA 510(k)

FDA Class 2 ·Microbiology

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

FDA 510(k)

FDA Class 2 ·Microbiology

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TRU LEGIONELLA

FDA 510(k)

FDA Class 2 ·Microbiology

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA STAT IGG/IGM TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA PNEUMOPHILA IGG/IGM

FDA 510(k)

FDA Class 2 ·Microbiology

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TRU Legionella

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

OSTEONICS(R) MID-SHAFT CEMENT SPACER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery