586 results · 48ms · Sources: EU EUDAMED, US FDA

ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS

FDA 510(k)
FDA Class 1 ·Immunology

Equipment, Rocket Immunoelectrophoresis

FDA classification
FDA Class 1 ·Equipment, Rocket Immunoelectrophoresis

Juzo Soft

FDA UDI
Julius Zorn, Inc.·00640095140429·20-30 mmHg, Soft, Knee, FF, Silicone, Cinnamon, V

Lumipulse G TP-N Calibrators

FDA registration
Fujirebio Inc.·1 product·🇯🇵 Japan

Syphilis IgM

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

Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit

FDA registration
Trinity Biotech USA·1 product·🇺🇸 United States

Antigen Substrate Slide

FDA registration
BION ENTERPRISES, LTD.·1 product·🇺🇸 United States

Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)

FDA registration
EUROIMMUN Medizinische Labordiagnostika AG·1 product·🇩🇪 Germany

i-STAT TBI Control Level 2

FDA registration
ABBOTT POINT OF CARE INC.·1 product·🇺🇸 United States

Borrelia All-In-One ViraChip Test Kit

FDA registration
VIRAMED BIOTECH AG·1 product·🇩🇪 Germany

Virgo FTA ABS IFA Kit

FDA registration
HEMAGEN DIAGNOSTICS, INC.·1 product·🇺🇸 United States

GFAP Reagent Kit (ARCHITECT, LN 4W16-27)

FDA registration
ABBOTT LABORATORIES·1 product·🇺🇸 United States

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit

FDA registration
GOLD STANDARD DIAGNOSTICS, LLC·1 product·🇺🇸 United States

LSR / REAGENT, BORRELIA SEROLOGICAL REAGENT

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

LABORATORIOS SCANTIBODIES S.A. DE C.V.

FDA registration
LABORATORIOS SCANTIBODIES S.A. DE C.V.·1 product·🇲🇽 Mexico

B. burgdorferi IgG/IgM ELIA, EIA-2809

FDA registration
DRG INSTRUMENTS GMBH·1 product·🇩🇪 Germany

GFAP Reagent Kit (Alinity i, LN 04W1722)

FDA registration
ABBOTT IRELAND·1 product·🇮🇪 Ireland

Borrelia B31 ViraChip IgG Test Kit

FDA registration
VIRAMED BIOTECH AG·1 product·🇩🇪 Germany

Lyme B. burgdorferi (IgM) MarStripe Test

FDA registration
IMMCO DIAGNOSTICS, INC.·1 product·🇺🇸 United States

Syphilis IgM

FDA registration
IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States