361 results · 27ms · Sources: EU EUDAMED, US FDA

MP RAPIDOXY TEST STRIP, MODEL 07RD-7073

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EMIT II OPIATES 300/2000 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Tetrabromo-M-Cresolsulfonphthalein, Albumin

FDA classification
FDA Class 2 ·Tetrabromo-M-Cresolsulfonphthalein, Albumin

Enzyme Immunoassay, Opiates

FDA classification
FDA Class 2 ·Enzyme Immunoassay, Opiates

Assisted Reproduction Laminar Flow Workstation

FDA classification
FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Accessory, Assisted Reproduction, Exempt

FDA classification
FDA Class 2 ·Accessory, Assisted Reproduction, Exempt

Dna And Rna Oncology Controls

FDA classification
FDA Class 2 ·Dna And Rna Oncology Controls

Hematopoietic Cell Enrichment Kit

FDA classification
FDA Class 2 ·Hematopoietic Cell Enrichment Kit

Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

FDA classification
FDA Class 2 ·Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification
FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Quality Control Material, Genetics, Rna

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

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

Whole Exome Sequencing Constituent Device

FDA classification
FDA Class 2 ·Whole Exome Sequencing Constituent Device

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification
FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

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