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SAS ASO-Latex

FDA UDI
SA SCIENTIFIC, LTD.·00780311000073·

AIM ASO TEST

FDA UDI
GERMAINE LABORATORIES, INC·00695684310509·Latex test for Anti-streptolysin O

GORE® CARDIOFORM Septal Occluder (GSO/Eclipse)

FDA registration
Sterigenics US LLC·1 product·🇺🇸 United States

ISO-DATA IMMUNOASSAY NETWORK SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DPM CALCULATOR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

APO A-I RIA KIT-HUMAN PLASMA APOLIP-

FDA 510(k)

ISO-DATA 500 SERIES GAMMA COUNTER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RIA SYSTEM, PARATHYROID HORMONE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

APO B RIA KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IDI GDR DATA REDUCTION SYSTEM

FDA 510(k)

IDI 200 GAMMA COUNTER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DUAL CHANNEL PULSE HEIGHT ANALYZER

FDA 510(k)
FDA Class 1 ·Radiology

ISO-DATA 100 SERIES GAMMA COUNTER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occluder (GSO)

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Septal Occluder (ASO/ASD)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE

ASO

Device
EU IVDR · Eu Ivd Class B ·Medicon Hellas SA·On the market·5 countries

ASO

Device
EU IVDR · Eu Ivd Class B ·Medicon Hellas SA·On the market·2 countries