NATtrol BD MAX Vaginal Panel External Controls

FDA 510(k)

FDA Class 2 ·Microbiology

MDx-Chex for BC-GP

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert CT/NG Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

MDx-Chex for BCID2

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray BCID2 Control Panel M416

FDA 510(k)

FDA Class 2 ·Microbiology

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire JI Control Panel M420

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert MRSA NxG Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX CT/GC/TV 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert SA Nasal Complete Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert C. difficile/Epi Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert Respiratory Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Global Fever Panel External Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618

FDA 510(k)

FDA Class 2 ·General Hospital