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

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Free Secretory Component, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Free Secretory Component, 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

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

Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

FDA classification

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

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

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

Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

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

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA classification

FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·ETHIBOND*

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNETOM

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICROL SYNTHETIC ABSORABLE SUTURE UNDYED

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERIDYNE DYNASPRAY