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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·VISTA LORDOTIC INTERBODY FUSION CAGE

Microfilter, Blood Transfusion

FDA classification

FDA Class 2 ·Microfilter, Blood Transfusion

Complement C1q, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C1q, Antigen, Antiserum, Control

Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nadh Oxidation/Nad Reduction, Ast/Sgot

FDA classification

FDA Class 2 ·Nadh Oxidation/Nad Reduction, Ast/Sgot

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

FDA classification

FDA Class 2 ·Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes