10,000 results · 403ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

DxSelect™ - Substrate Reagent

FDA UDI
DIASORIN MOLECULAR LLC·10816101022295·

PolyDetector HRP Black kit

FDA UDI
BIO SB, INC.·B502BSB0090B0·PolyDetector HRP Black Substrate-Chromogen used...

PolyDetector HRP Blue kit

FDA UDI
BIO SB, INC.·B502BSB01470·PolyDetector HRP Blue Substrate-Chromogen Kit i...

Xpert MRSA/SA SSTI

FDA UDI
CEPHEID·07332940000189·Xpert MRSA/SA SSTI kit; 10 test kit

Easy@Home Urinary Tract Infection Test Strips (10 Pack)

FDA UDI
EASY HEALTHCARE CORPORATION·00810038631448·Easy@Home Urinary Tract Infection Test Strips (...

Easy@Home Urinary Tract Infection Test Strips (20 Pack)

FDA UDI
EASY HEALTHCARE CORPORATION·00810038633473·Easy@Home Urinary Tract Infection Test Strips (...

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

AmpliVue

FDA UDI
QUIDEL CORPORATION·30014613312109·AmpliVue HSV 1+2 Assay

Procleix Tigris Lower Bay Fluids

FDA UDI
GRIFOLS DIAGNOSTIC SOLUTIONS INC.·00859882007399·A collection of reagents and other associated m...

PANTHER FUSION

FDA UDI
Hologic, Inc.·15420045509276·

Aptima®

FDA UDI
Hologic, Inc.·15420045507227·Aptima® HSV 1 & 2 Assay, 100 test, box 2 of 2 (...

Aptima®

FDA UDI
Hologic, Inc.·15420045500266·The Aptima® System Fluid Preservative Kit is us...

HSV 1&2 ELITe MGB Assay

FDA UDI
Elitechgroup Mdx LLC·03661540950025·HSV 1&2 ELITe MGB Assay for the detection of HS...

Xpert MRSA NxG

FDA UDI
CEPHEID·07332940001728·Xpert MRSA NxG kit: 120 test kit

Progensa

FDA UDI
Hologic, Inc.·15420045500785·

Procleix Tigris Lower Bay Fluids

FDA UDI
GRIFOLS DIAGNOSTIC SOLUTIONS INC.·00859882007382·A collection of reagents and other associated m...

PANTHER FUSION

FDA UDI
Hologic, Inc.·15420045509252·

Simplexa™ HSV 1 & 2 Direct

FDA UDI
DIASORIN MOLECULAR LLC·20816101025507·

ARIES® MRSA Assay

FDA UDI
LUMINEX CORPORATION·00840487101445·The ARIES® MRSA Assay is an integrated real-tim...

BD GeneOhm™ MRSA ACP Lysis Kit

FDA UDI
Geneohm Sciences Canada Inc·00382904416386·BD GeneOhm™ MRSA ACP Lysis Kit