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

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

Haptoglobin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Haptoglobin, Fitc, Antigen, Antiserum, Control

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

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA classification

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

FDA classification

FDA Class 2 ·Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate

FDA classification

FDA Class 2 ·Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt