FilmArray RP2/RP2plus Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima CMV Quant Assay

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

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

Great Basin Bordetella Direct Test

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

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire JI Control Panel M420

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

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

ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA

FDA 510(k)

FDA Class 2 ·Microbiology