ACA VANCOMYCIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multi Modality Viewer

FDA 510(k)

FDA Class 2 ·Radiology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

FDA 510(k)

FDA Class 2 ·Hematology

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRONEX RADIATION THERAPY CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CAPOGEN Laser Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

FDA 510(k)

FDA Class 2 ·Immunology

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DUPONT LIPASE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry