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IVDR-00452
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SUPREME HCG PREGNANCY RAPID TEST CASSETTE
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Hangzhou Biotest Biotech Co., Ltd. - 17# Futai Road, Zhongtai St., Yuhang District, Hangzhou P.R. China
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China
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24 May 2021
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29 November 2025
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IVDR-00453
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SUREBLISS ONE STEP URINE PREGNANCY TEST
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Hangzhou Biotest Biotech Co., Ltd. - Hangzhou, P.R. China
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China
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25 March 2021
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29 November 2025
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IVDR-00454
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GRACE HCG PREGNANCY RAPID TEST CASSETTE
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Hangzhou Biotest Biotech Co., Ltd. - 17# Futai Road, Zhongtai St., Yuhang District, Hangzhou P.R. China
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China
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24 May 2021
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29 November 2025
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IVDR-00455A
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ATELLICA™ IM HEPATITIS B CORE TOTAL (HBcT) ASSAY
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Siemens Healthcare GmbH
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USA
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02 December 2019
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02 December 2020
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IVDR-00455B
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ATELLICA™ IM HEPATITIS B CORE TOTAL (HBcT QC) QUALITY CONTROL
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Siemens Healthcare GmbH
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USA
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02 December 2019
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02 December 2020
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IVDR-00456A
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ATELLICA™ IM HEPATITIS B CORE ANTIGEN ASSAY (aHBcM)
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Siemens Healthcare GmbH
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USA
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02 December 2019
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02 December 2020
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IVDR-00456B
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ATELLICA™ IM HEPATITIS B CORE ANTIGEN QUALITY CONTROL (aHBcM QC)
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Siemens Healthcare GmbH
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USA
|
02 December 2019
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02 December 2020
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IVDR-00457A
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ATELLICA™ IM ANTI-HEPATITIS B e ANTIGEN (aHBe) ASSAY
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Siemens Healthcare GmbH
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USA
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02 December 2019
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02 December 2020
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| View |
IVDR-00457B
|
ATELLICA™ IM ANTI-HEPATITIS B e QUALITY CONTROL (aHBe QC)
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Siemens Healthcare GmbH
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USA
|
02 December 2019
|
02 December 2020
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| View |
IVDR-00458
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SUPERB HCG PREGNANCY RAPID TEST CASSETTE
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Hangzhou Biotest Biotech Co., Ltd. - 17# Futai Road, Zhongtai St., Yuhang District, Hangzhou P.R. China
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China
|
24 May 2021
|
02 December 2025
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| View |
IVDR-00459
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DIA.PRO HBsAG ONE VERSION ULTRA (Reagent, Control and Calibrator)
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Dia.Pro Diagnostic Bioprobes S.r.l. - Via G. Carducci, 27-20099 - Sesto San Giovanni-Milano-Italy
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Italy
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17 December 2020
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02 December 2025
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IVDR-00460
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VIDAS HBC IGM II
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BIOMERIEUX S.A.
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FRANCE
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06 December 2019
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06 December 2020
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| View |
IVDR-00461
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BIOLINE LEPTOSPIRA IgM (CASSETTE TYPE)
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Abbott Diagnostics Korea Inc. - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic of Korea
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Korea
|
15 February 2021
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06 December 2025
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| View |
IVDR-00462
|
VIDAS HIV DUO UHRA
|
BIOMERIEUX S.A.
|
FRANCE
|
06 December 2019
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06 December 2020
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| View |
IVDR-00463
|
VIDAS HBSAG ULTRA
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BIOMERIEUX S.A.
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FRANCE
|
06 December 2019
|
06 December 2020
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| View |
IVDR-00464
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BD TRITEST REAGENT CD4 FITC/CD8 PE/CD3 PERCP
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BECTON DICKINSON HOLDINGS PTE.LTD.
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USA
|
06 December 2019
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06 December 2020
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| View |
IVDR-00465
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BD SIMULTEST REAGENT CD4/CD8 (LEU ™-3A/2A)
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BECTON DICKINSON HOLDINGS PTE.LTD.
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USA
|
06 December 2019
|
06 December 2020
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| View |
IVDR-00466A
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HISCL™ ANTI-Hbe ASSAY KIT
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Sysmex Asia Pte Ltd. - 9 Tampines Grande, #06-18, Singapore 528735 mfd. By: Japan Lyophilization Laboratory, Kiyose Factory - 3-1-5 Matsuyama, Kiyose-shi, Tokyo, 204-0022 Japan For: Sysmex Corporation - 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe, 651-0073, Japan
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Japan
|
22 January 2021
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06 December 2025
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| View |
IVDR-00466B
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HISCL™ ANTI-Hbe CALIBRATOR
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Sysmex Asia Pacific Pte. Ltd. - Singapore mfd. By: Japan Lyophilization Laboratory - Tokyo, Japan For Sysmex Corporation - Kobe, Japan
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Japan
|
08 March 2021
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06 December 2025
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| View |
IVDR-00468
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VIDAS HBs AG ULTRA (REAGENT KIT), CALIBRATOR & CONTROL
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Biomerieux Singapore Pte. Ltd.
|
France
|
14 January 2020
|
14 January 2021
|