191 results · 44ms · Sources: EU EUDAMED, US FDA

Affymetrix

FDA UDI
AFFYMETRIX, INC.·00856826006111·CytoScan® Dx Wash Solution B

Affymetrix

FDA UDI
AFFYMETRIX, INC.·00856826006081·CytoScan® Dx Array

Affymetrix

FDA UDI
AFFYMETRIX, INC.·00856826006142·CytoScan® Dx Pre-PCR -20°C MOD R L A

GenetiSure Dx Wash Buffer 1

FDA UDI
AGILENT TECHNOLOGIES, INC.·05700571112632·GenetiSure Dx Wash Buffer 1

GenetiSure Dx Cot-1 Human DNA

FDA UDI
AGILENT TECHNOLOGIES, INC.·05700571112656·GenetiSure Dx Cot-1 Human DNA

CYTOSCAN(R) DX

FDA 510(k)
FDA Class 2 ·Immunology

GenetiSure Dx Postnatal Assay

FDA 510(k)
FDA Class 2 ·Immunology

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

FDA classification
FDA Class 2 ·System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

FDA registration
BioFire Defense, LLC·1 product·🇺🇸 United States

SPOTFIRE RSP Positive Control

FDA registration
MAINE MOLECULAR QUALITY CONTROLS, INC.·1 product·🇺🇸 United States

MDx-Chex for BC-GP

FDA registration
STRECK LLC·1 product·🇺🇸 United States

BD MAX™ Enteric Parasite 20-Day QC Panel

FDA registration
MICROBIOLOGICS, INC.·1 product·🇺🇸 United States

Procleix® WNV/Babesia Quality Control

FDA registration
Grifols Diagnostic Solutions Inc.·1 product·🇺🇸 United States

Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening

FDA registration
DaklaPack US Inc.·1 product·🇺🇸 United States

MDx-Chex for BC-GN

FDA registration
STRECK LLC·1 product·🇺🇸 United States

Amplichek II

FDA registration
Bio-Rad Laboratories Inc.·1 product·🇺🇸 United States

BioFire JI Control Panel M420

FDA registration
MAINE MOLECULAR QUALITY CONTROLS, INC.·1 product·🇺🇸 United States

Savanna RVP Control Set

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

FilmArray BCID2 Control Panel M416

FDA registration
MAINE MOLECULAR QUALITY CONTROLS, INC.·1 product·🇺🇸 United States

Assayed MRSA NxG Control Panel

FDA registration
MICROBIOLOGICS, INC.·1 product·🇺🇸 United States