ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800

FDA 510(k)

FDA Class 2 ·Immunology

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Cystic Fibrosis 39 Kit v2

FDA 510(k)

FDA Class 2 ·Immunology

XTAG CF60 KIT V2

FDA 510(k)

FDA Class 2 ·Immunology

INPLEX CF MOLECULAR TEST

FDA 510(k)

FDA Class 2 ·Immunology

CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01

FDA 510(k)

FDA Class 2 ·Immunology

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

gSource

FDA UDI

GSOURCE LLC·00840314233899·Leksell-Stille Rongeur 9 1/2" cvd 8mm DA

Puritan5503 (NR) - Puritan, OptiSwab, Liquid Aimes Collection and Transport System

FDA registration

ISOMEDIX OPERATIONS INC.·3 products·🇺🇸 United States

Puritan Liquid Amies Swab Collection and Transport System

FDA registration

Gamma Centre of Excellence·3 products·🇨🇦 Canada

ARX Liquid Amies Collection & Transport System

FDA registration

ARX SCIENCES·3 products·🇺🇸 United States

Puritan Medical Products Company LLC

FDA registration

PURITAN MEDICAL PRODUCTS COMPANY LLC·3 products·🇺🇸 United States

Synergy Health Sterilisation UK Ltd

FDA registration

Synergy Health Sterilisation UK Ltd·2 products·🇬🇧 United Kingdom

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM

FDA registration

Baxter Healthcare of Puerto Rico LLC·2 products·🇺🇸 United States

Sterigenics Italy SpA

FDA registration

Sterigenics Italy SpA·2 products·🇮🇹 Italy