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IVDR-00613
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Wantai Aid™ Anti-HCV ELISA plus Hepatitis C Virus Antibody ELISA
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. No. 31 Kexueyuan Road, Changping District, Beijing, China
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China
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24 January 2023
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29 July 2027
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IVDR-00614
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PinkCheck®Early Pregnancy Test Kit (Midstream)
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Anhui Deepblue Medical Technology Co., Ltd. - 4th Floor, D-1#Zone, Pearl industrial Park, 106 Innovation Avenue, High-Tech Development Zone, 230088 Hefei, Anhui, People`s Republic of China
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China
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13 July 2023
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29 July 2027
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IVDR-00615
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Matrix ABO/Rho (D) Forward and Reverse Grouping with Autocontrol
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Tulip Diagnostics (P) Ltd. Gitanjali, Tulip Block, Dr. anotonio Do Rego Bagh, Alto Santacruz. Bambolim Complex, Goa, India Mfd. By: Tulip Diagnostics (P) Ltd. - 92/96 Phase IIC, Verna Indutrial Estate, Verna, Goa, 403 772, India
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India
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17 March 2023
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29 July 2027
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IVDR-00616
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Matrix ABO/Rho (D) Forward Grouping Confirmation Card
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Tulip Diagnostics (P) Ltd. Gitanjali, Tulip block, Dr Antonio Do Rego Bagh, Alto Santacruz, Bambolim Complex Goa, India Mfd. By: Tulip Diagnostics (P) Ltd. - 92/96, Phase IIC, Verna Industrial Estate, Verna Goa, India
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India
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09 March 2023
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29 July 2027
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IVDR-00617
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Matrix™ Gel System Forward Grouping and Crossmatch Card
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Tulip Diagnostics (P)Ltd. Gitanjali, Tulip Block, Dr. Antonio Do Rego Bagh, Alto Santa Cruz, Bambolim Complex P.O. Goa India Mfd. By: Tulip Fiadnostics (P) Ltd. - Plot No.s 92/96, Phase IIC, Verna Industrial Estate, Verna, Goa - 403722, India
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India
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04 November 2022
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29 July 2027
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IVDR-00618
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Gamma - N - Hance Low ionic Strength Additive Solution for Antibody Detection Tests
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Immucor, Inc. - 3130 Gateway Drive, Norcross GA 30071,USA
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USA
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30 August 2022
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29 July 2027
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IVDR-00619
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DG GEL ABO/Rh 92D) (RT)
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Grifols International, S.A. - Barcelona, Spain mfd. By: Diagnostic Grifols, S.A. - Barcelona, Spain
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Spain
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12 August 2021
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12 August 2022
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IVDR-00620
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Rapiquick HBsAb Rapid Test Device
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Hangzhou AllTest Biotech Co., Ltd. 550#, Yinhai Street, Hangzhou Economic and Technological and Development Area, 310018 Hangzhou, P.R. China
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China
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08 June 2022
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12 August 2027
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IVDR-00621
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DG GEL ANTI-IgG
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Grifols International, S.A. - Barcelona, Spain mfd. By: Diagnostic Grifols S.A. - Barcelina, Spain
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Spain
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12 August 2021
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12 August 2022
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IVDR-00622A
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C.f.a.s DAT Qualitative Plus
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Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Mannheim, Germany
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Germany
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12 August 2022
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23 August 2027
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IVDR-00622B
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C.F.A.S. DAT QUALITATIVE PLUS CLINICAL
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00623A
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PRECISET DAT PLUS 1
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00623B
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PRECISET DAT PLUS II CAL DAT QUALITATIVE PLUS CLINICAL
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00624A
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COBAS CONTROL SET DAT I
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00624B
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COBAS CONTROL SET DAT II
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00624C
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COBAS CONTROL SET DAT III
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00625
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ONLINE DAT COCAINE II
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00626
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ONLINE DAT OPIATES II
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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IVDR-00627
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ONLINE DAT AMPHETAMINES II
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
|
23 August 2021
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23 August 2022
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IVDR-00628
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COBAS CONTROL SET DAT CLINICAL
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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23 August 2021
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23 August 2022
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