580 results · 40ms · Sources: EU EUDAMED, US FDA

Respiratory Syncytial Virus - Elisa

FDA classification
FDA Class 1 ·Respiratory Syncytial Virus - Elisa

Mass Spectrometry, Microorganism Identification, Blood Culture

FDA classification
FDA Class 2 ·Mass Spectrometry, Microorganism Identification, Blood Culture

Dna-Reagents, Cytomegalovirus

FDA classification
FDA Class 2 ·Dna-Reagents, Cytomegalovirus

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification
FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Antigen, Cf (Including Cf Control), Mumps Virus

FDA classification
FDA Class 1 ·Antigen, Cf (Including Cf Control), Mumps Virus

Antisera, Fluorescent, All Types, Hemophilus Spp.

FDA classification
FDA Class 2 ·Antisera, Fluorescent, All Types, Hemophilus Spp.

Antigens, Ha, Treponema Pallidum

FDA classification
FDA Class 2 ·Antigens, Ha, Treponema Pallidum

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification
FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Cancer Predisposition Risk Assessment System

FDA classification
FDA Class 2 ·Cancer Predisposition Risk Assessment System

System, Detection, Bacterial, For Platelet Transfusion Products

FDA classification
FDA Class 1 ·System, Detection, Bacterial, For Platelet Transfusion Products

Quality Control Material, Genetics, Dna

FDA classification
FDA Class 2 ·Quality Control Material, Genetics, Dna

Whole Exome Sequencing Constituent Device

FDA classification
FDA Class 2 ·Whole Exome Sequencing Constituent Device

Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)

FDA classification
FDA Class 1 ·Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)

Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

FDA classification
FDA Class 2 ·Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

Test, Donor, Syphilis, Antigens, Treponemal

FDA classification
FDA Class 2 ·Test, Donor, Syphilis, Antigens, Treponemal

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification
FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System

Bcr/Abl1 Monitoring Test

FDA classification
FDA Class 2 ·Bcr/Abl1 Monitoring Test

Test, Vaginal, Bacterial Sialidase

FDA classification
FDA Class 1 ·Test, Vaginal, Bacterial Sialidase

Anti-Phospholipase A2 Receptor

FDA classification
FDA Class 2 ·Anti-Phospholipase A2 Receptor

Jak2 Gene Mutation Detection Test

FDA classification
FDA Class 2 ·Jak2 Gene Mutation Detection Test