10,000 results · 47ms · Sources: EU EUDAMED, US FDA

SAS Strep Alert

FDA registration
SA SCIENTIFIC, LTD·1 product·🇺🇸 United States

ZHEJIANG ORIENT GENE BIOTECH

FDA registration
ZHEJIANG ORIENT GENE BIOTECH·1 product·🇨🇳 China

Clarity Rapid Strep A test

FDA registration
Clarity Diagnostics, LLC·1 product·🇺🇸 United States

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Absorb GTi Bioresorbable Vascular Scaffold (BVS) System

Positive Serum Control

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500643·For Use with PakPlus

Negative Serum Control

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500513·For Use with Pak12G

DonorScreen-HLA® Class I and Class II Additional Reagents

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500186·DonorScreen-HLA Class I and Class II assay is a...

Negative Serum Control

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500537·For Use with PakAuto

LIFECODES MATCH IT!™ DNA Software v1.2

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234400394·

Anti-Human IgG/A/M Conjugate

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500391·For Use with PF4 Enhanced (X-HAT13 & X-HAT45)

Positive Platelet Control (Positive Eluate Control)

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500568·For Use with PakAuto

LIFECODES LSA Class II

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234400349·LIFECODES LSA Class II is a bead-based Immunoas...

PF4 Enhanced®

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500032·PF4 Enhanced assay is a qualitative solid phase...

Dilution Solution

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234400745·For Use with HLA-SSO Typing Kits

Specimen Diluent

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500353·For Use with PF4 Enhanced (X-HAT13 & X-HAT45) a...

LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234400059·DNA Typing of Class I HLA alleles, to aid in tr...

Negative Control

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500339·For Use with Factor VIII Antibody Screen

PakAuto®

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500728·PakAuto assay is a qualitative solid phase enzy...

LIFECODES Wash Buffer

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234400578·For Use with LIFECODES Class I ID and LIFECODES...

Negative Control Serum

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234400622·For Use with LIFECODES Class II IDv2