1,186 results · 34ms · Sources: EU EUDAMED, US FDA

SKOUT system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAGENTIQ-COLO (ME-APDS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EndoScreener

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CADDIE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Fluorion HCV QNP 2.1 Real-Time PCR

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion BKV QNP 1.0 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion HDV QNP 1.0 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion CMV QNP 3.0 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion HBV QNP 2.0 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion EBV QNP 1.0 EBV Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Gastrointesinal Lesion Software Detection System

FDA classification
FDA Class 2 ·Gastrointesinal Lesion Software Detection System

AUTO I.D.® Sm/RNP Autoantibody Test System

FDA UDI
IMMUNO CONCEPTS INC·M7490600111·AUTO I.D.® RNP Control - 1 x 0.5 ml

AUTO I.D.® Sm/RNP Autoantibody Test System

FDA UDI
IMMUNO CONCEPTS INC·M7490600211·AUTO I.D.® Sm/RNP Control - 1 x 0.5 ml