HE4 EIA

FDA registration

Fujirebio Diagnostics AB·1 product·🇸🇪 Sweden

Synergy Health Sterilisation UK Ltd

FDA registration

Synergy Health Sterilisation UK Ltd·2 products·🇬🇧 United Kingdom

HE4 EIA

FDA registration

Fujirebio Diagnostics, AB·1 product·🇸🇪 Sweden

HE4 ELISA

FDA registration

IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States

Alinity i HE4 Reagent Kit

FDA registration

Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

Paragon Adult Maxi PMP Oxygenator

FDA registration

Chalice Medical Ltd·2 products·🇬🇧 United Kingdom

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS

MODIFIED IMAGEN(TM) CHLAMYDIA TEST

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

FDA 510(k)

FDA Class 2 ·Hematology

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

FDA 510(k)

FDA Class 1 ·Microbiology

SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMAGEN CHLAMYDIA TEST

FDA 510(k)

FDA Class 1 ·Radiology

IMAGEN INFLUENZA VIRUS A AND B TESTMI

FDA 510(k)

FDA Class 1 ·Microbiology

MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST

FDA 510(k)

FDA Class 1 ·Microbiology

IDEIA HERPES SIMPLEX VIRUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SUCROSEP HUMAN PROLACTIN (HPR) IRMA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OVEIA (TM) DUAL ANALYTE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry