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