Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test

Lyra Direct HSV 1+2/VZV Assay

FDA registration

Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Alinity m HSV 1 & 2 / VZV CTRL Kit (09N61-085)

FDA registration

ABBOTT MOLECULAR, INC.·1 product·🇺🇸 United States

Elite InGenius

FDA registration

PRECISION SYSTEM SCIENCE COMPANY LIMITED·1 product·🇯🇵 Japan

MOL2175 Simplexa HSV 1/2 & VZV Universal Direct

FDA registration

DiaSorin Molecular LLC·1 product·🇺🇸 United States

Alinity m HSV 1 & 2 / VZV Application Specification File

FDA registration

ABBOTT MOLECULAR, INC.·1 product·🇺🇸 United States

HERPES SIMPLEX VIRUS (HSV) 1.2 & VZV Panel PCR

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

Solana HSV 1+2/VZV Assay

FDA registration

Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

HSV 1/2 IgM Rapid Test Cassette

FDA registration

ACRO BIOTECH Inc.·1 product·🇺🇸 United States

KTR-1031 Herpes Simplex Virus Type II (HSV-2) IgM ELISA Kit

FDA registration

EPITOPE DIAGNOSTICS, INC.·1 product·🇺🇸 United States

280650, illumigene HSV 1&2

FDA registration

MERIDIAN BIOSCIENCE, INC.·1 product·🇺🇸 United States

ANA/LITE-HEP-2 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME IMMUNOASSAY ANA SCREENING TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER

FDA 510(k)

FDA Class 2 ·Immunology

NOVA 5 NA/K/C1 ALALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EL-ANA PROFILES: EL-ENA/5

FDA 510(k)

FDA Class 2 ·Immunology

EL-ANA PROFILES: EL-ENA/4

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANA IFA: HEP-20-10

FDA 510(k)

FDA Class 2 ·Immunology