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IVDR-00469
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GREAT 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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11 June 2021
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14 January 2026
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IVDR-00470
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ICHECK RAPID SCREENING TEST LEPTOSPIRA IgG/IgM RAPID TEST CASSETTE
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Hangzhou Alltest Biotech Co., Ltd. - Yinhai St., Hangzhou Economic Technological Development Area, Hangzhou, People's Republic of China
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China
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12 May 2021
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16 January 2026
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IVDR-00471
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iCheck One step Pregnancy Test Device (Urine)
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Hangzhou Alltest Biotech Co., Ltd. 550# Yinhai Street, Hangzhou Economic and Technological Development Area, 310018 Hangzhou, People's Republic of China
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China
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24 May 2022
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11 February 2026
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IVDR-00472
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VIDAS ANTI-HBC TOTAL II REAGENT, CALIBRATOR AND CONTROL KIT
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Biomerieux S.A
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France
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12 February 2020
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12 February 2021
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IVDR-00473
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CELL-FREE DNA COLLECTION TUBE
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Roche Diagnostics GmbH - Mannheim, Germany mfd. By: Greiner Bio-One GmbH - Osterreich, Austria
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Austria
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15 July 2021
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12 February 2026
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IVDR-00474A
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LIAISON® ANTI-HBE
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DiaSorin S.p.A. - Via Crescentino snc, 13040 Saluggia (VC), Italy
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Italy
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12 May 2021
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14 February 2026
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IVDR-00474B
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LIAISON® CONTROL ANTI-HBE
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DiaSorin S.p.A. - Via Crescentino snc, 13040 Saluggia (VC), Italy
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Italy
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12 May 2021
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14 February 2026
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IVDR-00475A
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ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (aHBs2) ASSAY
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Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, NY, United States
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USA
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16 September 2021
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14 February 2026
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IVDR-00475B
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ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 QUALITY CONTROL (aHBs2-QC)
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Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, NY, United States
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USA
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16 September 2021
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14 February 2026
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IVDR-00476
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ABD PAD®
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Diagast - Loos, France
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France
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21 April 2021
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14 February 2026
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IVDR-00477A
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ARCHITECT ANTI-HBs REAGENT KIT
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Abbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, Ireland
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Ireland
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08 March 2021
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18 February 2026
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IVDR-00477B
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ARCHITECT ANTI-HBs REAGENT KIT WITH AUTO-DILUTION
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Abbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, Ireland
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Ireland
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08 March 2021
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18 February 2026
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IVDR-00477C
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ARCHITECT ANTI-HBs SPECIMEN DILUENT
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Abbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, Ireland
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Ireland
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08 March 2021
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18 February 2026
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IVDR-00477D
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ARCHITECT ANTI-HBs CALIBRATOR
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Abbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, Ireland
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Ireland
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08 March 2021
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18 February 2026
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IVDR-00477E
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ARCHITECT ANTI-HBs CONTROL
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Abbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, Ireland
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Ireland
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08 March 2021
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18 February 2026
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IVDR-00478
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ARCHITECT SYPHILIS TP REAGENT KIT
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Abbott GmbH & Co. KG - Maz-Planck-Ring 2, 65205 Wiesbaden, Germany
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Germany
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01 February 2021
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18 February 2026
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IVDR-00479A
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COBAS® HCV GT
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Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305, Mannheim, Germany mfd. By: Roche Molecular Systems, Inc. - 1080 US Highway 202 South, Branchburg, NJ, 08876, United States
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USA
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15 February 2021
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03 March 2026
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IVDR-00479B
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COBAS® HCV GT CONTROL KIT
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Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305, Mannheim, Germany mfd. By: Roche Molecular Systems, Inc. - 1080 US Highway 202 South, Branchburg, NJ, 08876, United States
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USA
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15 February 2021
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03 March 2026
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IVDR-00480
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COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, VERSION 2.0
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Roche Molecular Systems, Inc. - Branchburg, NJ, USA
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USA
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25 March 2021
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03 March 2026
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IVDR-00481
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COBAS® AMPLIPREP/COBAS® TAQMAN® HCV QUANTITATIVE TEST, VERSION 2.0
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Roche Molecular Systems Inc. - 1080 US Highway 202 South, Branchburg, NJ, 08876, United State
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USA
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16 July 2021
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03 March 2026
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