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IVDR-00313
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BIOLINE™Syphilis 3.0
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Abbott Diagnostics Korea Inc. - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
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Korea
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19 July 2022
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09 August 2026
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IVDR-00315
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DIA.PRO SYPHILIS AB VERSION ULTRA REAGENTS, CALIBRATOR AND CONTROL
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DIA.PRO Diagnostic BioProbes S.r.l.
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Italy
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22 August 2019
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09 March 2024
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IVDR-00317
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SERODIA HIV 1/2 MIX
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Fujirebio Inc.
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Japan
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10 December 2018
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09 March 2024
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IVDR-00320
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CLEARBLUE PREGNANCY TEST
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SPD Swiss Precision Diagnostics GmbH
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China
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14 June 2019
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26 April 2024
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| View |
IVDR-00321
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Hemalys 1 A1, B
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Diagast 251 avenue Eugene Avinee, Eurasante Parc 59120 Loos France
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France
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07 February 2024
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26 April 2029
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IVDR-00322
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Bromeline
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Diagast 251 avenue Eugene Avinee, Eurasante Parc 59120 Loos France
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France
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07 February 2024
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26 April 2029
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IVDR-00323
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DIAGAST HEMASCREEN
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Diagast
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France
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24 May 2018
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18 July 2023
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IVDR-00324
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DIAGAST SCREENLYS
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Diagast
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France
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24 May 2018
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19 July 2023
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IVDR-00325
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COBAS® TAQMAN® HIV-1 TEST V2.) KIT
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Roche Molecular Systems, Inc.
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USA
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14 June 2019
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29 May 2024
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| View |
IVDR-00326
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DG GEL COOMBS
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Grifols International S.A.
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Spain
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02 January 2020
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13 June 2024
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| View |
IVDR-00327
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XPERT® HIV-1 QUAL ASSAY
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Cepheid AB
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Sweden
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22 July 2019
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13 June 2024
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| View |
IVDR-00328
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XPERT® HCV VIRAL LOAD
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Cepheid AB
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Sweden
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18 July 2019
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13 June 2024
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IVDR-00330A
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Vitros Immunodiagnostic Products Total β-hCG II Reagent Pack
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Ortho-Clinical Diagnostics Felindre Meadows Pencoed, Bridgend, CF35 5PZ United Kingodm
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United Kingdom
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17 March 2023
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29 November 2027
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IVDR-00330B
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Vitros Immunodiagnostic Products Total β-hCG II Calibrator
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Ortho-Clinical Diagnostics Felindre Meadows Pencoed, Bridgend, CF35 5PZ United Kingodm
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United Kingdom
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17 March 2023
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29 November 2027
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IVDR-00331A
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COBAS® TAQMAN GHB TEST
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Roche Molecular Systems, Inc.
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USA
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16 May 2019
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20 July 2024
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| View |
IVDR-00331B
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COBAS TAQMAN HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT
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Roche Molecular Systems, Inc.
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USA
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22 August 2019
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20 July 2024
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IVDR-00332
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WANTAI AID™ ANTI-HIV 1 & 2 ELISA
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
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China
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14 October 2019
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17 August 2024
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IVDR-00333A
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ARCHITECT ANTI-HBC IGM REAGENT KIT
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Abbott GmbH & Co. KG
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Germany
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14 October 2019
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20 August 2024
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| View |
IVDR-00333B
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ARCHITECT ANTI-HBC IGM CALIBRATOR
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Abbott GmbH & Co. KG
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Germany
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14 October 2019
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20 August 2024
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| View |
IVDR-00333C
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ARCHITECT ANTI-HBC IGM CONTROL
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Abbott GmbH & Co. KG
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Germany
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14 October 2019
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20 August 2024
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