GERMAINE LABORATORIES, INC.

FDA registration

GERMAINE LABORATORIES, INC.·1 product·🇺🇸 United States

LIQUID QC URINE CHEM CONTROL 1&2

FDA registration

CLINIQA CORPORATION·1 product·🇺🇸 United States

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

for Pipercillin/Tazobactam

FDA registration

BIOMERIEUX, INC.·1 product·🇺🇸 United States

for Pipercillin/Tazobactam

FDA registration

bioMerieux, Inc.·1 product·🇺🇸 United States

MVM / Autoantibodies, endomysial(tissue transglutaminase)

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

Scimedx IFA Anti-EMA(PUC) IgA Assay (Endomysial Antibody)

FDA registration

SCIMEDX CORP.·1 product·🇺🇸 United States

Endomysial Antibody IFA

FDA registration

IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States

Endomysial

FDA registration

Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

DENTAL IMPLANTS - ACCESSORIES

Device

EU MDR · Eu Md Class 1 ·Southern Implants (Pty) Ltd·On the market·12 countries

Ponto bone anchored hearing system

FDA registration

CENOVA AB·1 product·🇸🇪 Sweden

OrthoCAD iQ

FDA registration

Align Technology de Costa Rica La Lima Center·3 products·🇨🇷 Costa Rica

LIVESURE PHENECYCLINE (PCP) SCREEN TESTS

FDA 510(k)

FDA Unclassified ·Unknown

IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.

FDA 510(k)

FDA Class 2 ·Immunology

Multi-Analyte Controls, All Kinds (Assayed)

FDA classification

FDA Class 1 ·Multi-Analyte Controls, All Kinds (Assayed)

Autoantibodies, Endomysial(Tissue Transglutaminase)

FDA classification

FDA Class 2 ·Autoantibodies, Endomysial(Tissue Transglutaminase)

Enzyme Immunoassay, Phencyclidine

FDA classification

FDA Unclassified ·Enzyme Immunoassay, Phencyclidine