276 results · 19ms · Sources: EU EUDAMED, US FDA

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

FDA 510(k)
FDA Class 2 ·Microbiology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

BD DIRECTIGEN EZ FLU A+B ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

XPECT FLU A & B

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Haptoglobin, Fitc, Antigen, Antiserum, Control

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

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

Test, Sorbent, Fta-Abs

FDA classification
FDA Class 2 ·Test, Sorbent, Fta-Abs

Anti-Human Globulin, Fta-Abs Test

FDA classification
FDA Class 2 ·Anti-Human Globulin, Fta-Abs Test

Antisera, Fluorescent Antibody For Fta-Abs Test

FDA classification
FDA Class 2 ·Antisera, Fluorescent Antibody For Fta-Abs Test

Antigen, Treponema Pallidum For Fta-Abs Test

FDA classification
FDA Class 2 ·Antigen, Treponema Pallidum For Fta-Abs Test

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

FDA classification
FDA Class 2 ·Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Devices Detecting Influenza A, B, And C Virus Antigens

FDA classification
FDA Class 2 ·Devices Detecting Influenza A, B, And C Virus Antigens

Sera, Reactive And Non-Specific Control, Fta-Abs Test

FDA classification
FDA Class 2 ·Sera, Reactive And Non-Specific Control, Fta-Abs Test