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 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 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

GE Medical Systems Polska Sp. z o.o.

Importer

🇵🇱 Poland

GE Healthcare Austria GmbH & Co OG

Importer

🇦🇹 Austria·1 Manufacturer

GE Healthcare Austria GmbH & Co OG

Importer

🇦🇹 Austria

1434-IVDD-029/2019

Certificate

IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-030/2019

Certificate

IVDD Annex IV (excluding sections 4, 6)·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-115/2022

Certificate

IVDD Annex IV (excluding sections 4, 6)·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-114/2022

Certificate

IVDD Annex IV (excluding sections 4, 6)·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-113/2022

Certificate

IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-153/2018

Certificate

IVDD Annex IV (excluding sections 4, 6)·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-152/2018

Certificate

IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-025/2019

Certificate

IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-026/2019

Certificate

IVDD Annex IV (excluding sections 4, 6)·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

BY-GL-A-1,BY-GL-C-1,BY-GL-1(A),BY-GL-1(B),BY-GL-1(C),BY-GL-1(D),BY-GL-1(E), BY-GL-1(F),BY-GL-A-1(A),BY-GL-A-2,BY-GL-A-2(A),BY-GL-A-3,BY-GL-A-3(A),BY-GL-A-4,BY-GL-A-4(A),BY-GL-A-5,BY-GL-A-5(A),BY-GL-C-1(A),BY-GL-C-2,BY-GL-C-2(A),BY-GL-E-1

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Ningbo Boya Medical Equipment Co., Ltd·4 devices

Analyzer

FDA registration

Diamond Diagnostics Inc.·29 products·🇭🇺 Hungary

COBAS INTEGRA SYSTEM

FDA registration

ROCHE DIAGNOSTICS GMBH·62 products·🇩🇪 Germany

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States