DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

TRACOR RA500 AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HARDY DISK, CEFPODOXINE, 10MCG

FDA 510(k)

FDA Class 2 ·Microbiology

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADENOVIRUS R-GENE US

FDA 510(k)

FDA Class 2 ·Microbiology

NOBELPHARMA BONE ANCHORED HEARING AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert Respiratory Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

CRAG LATERAL FLOW ASSAY (CRAG LFA)

FDA 510(k)

FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

CEFDINIR, 5 UG, SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

GuideWire

FDA 510(k)

FDA Class 2 ·Neurology

'EXMOOR' DAS GUPTA LARYNGEAL KEEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MTS Omadacycline 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

JARIT RECOMMENDED SINUS INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ENZYGNOST(R) ANTI-CMV IGG

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

FDA 510(k)

FDA Class 2 ·Microbiology

CMV-EA MAB TEST

FDA 510(k)

FDA Class 2 ·Microbiology