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IVDR-00538B
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VIROCLEAR® UNASSAYED (HUMAN) SEROLOGY CONTROL; Size/Code: 00112- 10x4mL
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Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad Laboratories Inc. - Irvine, CA, United States
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USA
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07 October 2021
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01 December 2026
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IVDR-00539
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Rapiquick 2 in 1 Multi-Drug 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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29 December 2026
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IVDR-00540
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CLUNGENE® HCG PREGNANCY RAPID TEST CASSETTE
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Hangzhou Clongene Biotech Co., Ltd. - Hangzhou, China
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China
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29 December 2020
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29 December 2021
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IVDR-00541
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SURE-GUARD PREGNANCY TEST KIT RAPID TEST CASSETTE (URINE)
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Hangzhou Alltest Biotech Co., Ltd. - Hangzhou, People's Republic of China
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China
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05 January 2021
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05 January 2022
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IVDR-00542
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ADVIA CENTAUR® READY PACK® HBsII
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Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - Tarrytown, New York, USA
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USA
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07 January 2021
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07 January 2021
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IVDR-00543
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Beright HCG Pregnancy Tapid Test Dipstick
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Hangzhou AllTest Biotech Co., Ltd. 550#, yinhai Street, Hangzhou Economic and Technological Development Area 310018 Hangzhou, China
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China
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28 September 2022
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07 January 2027
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IVDR-00544
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Beright HCG Pregnancy Rapid Test Casette
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Hangzhou Alltest Biotech Co., Ltd - 550#, Yinhai Street Hangzhou Economic and Technological Development Area, 310018, Hangzhou, China
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China
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04 August 2022
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07 January 2027
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IVDR-00545
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Citest Leptospira IgG/IgM Rapid Test Cassette
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Citest Diagnostics Inc. - 170-422, Richards Street, Vancuover BC V6B 2Z4, Canada
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Canada
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22 August 2022
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13 January 2027
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IVDR-00546
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CITEST PREGNANCY (hCG) RAPID TEST CASSETTE
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Citest Diagnostics Inc. - Vancouver, Canada
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Canada
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13 January 2021
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13 January 2022
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IVDR-00547
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PRECICONTROL HIV GEN II
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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01 February 2021
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01 February 2022
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View |
IVDR-00548A
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ALINITY I HBeAg QUANTITATIVE CONTROLS
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Abbott GmbH - Wiesbaden, Germany
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Germany
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04 February 2021
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04 February 2022
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View |
IVDR-00548B
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ALINITY I HBeAg QUANTITATIVE CALIBRATOR
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Abbott GmbH - Wiesbaden, Germany
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Germany
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04 February 2021
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04 February 2022
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View |
IVDR-00549
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Sure-Guard Pregnancy Test Kit Dipstick (Urine)
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Hangzhou Alltest Biotech Co., Ltd. 550 Yinhai Hangzhou Economy and Technology Development Area, Hangzhou, P.R. China
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China
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21 December 2022
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04 February 2027
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IVDR-00550
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Murex HCV Ag/Ab Combination Immunoassay Kit
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Diasorin S.p.A-Saluggia (VC), Italy Mfd By: Diasorin S.p.A- UK Branch-Dartford, United Kingdom
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Italy
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25 January 2022
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04 February 2027
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IVDR-00551
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PREGNANCY RAPID TEST (URINE)
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Nantong Egens Biotechnology Co., Ltd. - Nantong, People of Republic of China
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China
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04 February 2021
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04 February 2022
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IVDR-00552
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SURE-GUARD PREGNANCY RAPID TEST (URINE)
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Nantong Egens Biotechnology Co., Ltd. - Nantong, People of Republic of China
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China
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04 February 2021
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04 February 2022
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IVDR-00553
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Biopanda Reagents Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
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Biopanda Reagents Ltd. Unit 14, Carrowreagh Business Park, Carrowreagh Road, Belfast, County Down, BT16 1QQ, United Kingdom
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United Kingdom
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14 February 2024
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09 February 2027
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IVDR-00554
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Bioline HIV 1/2 3.0 One Step Anti-HIV 1/2 Test
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Abbott Diagnostics, Inc. - 65, Borahagal-ro, Giheung-gi Yongin-si, Gyeonggi-do 17099, Republic of Korea
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Korea
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30 March 2022
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10 February 2027
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View |
IVDR-00555
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Murex Anti-HCV Version 4.0
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DiaSorin S.p.A - Via Crescentino, snc 13040 Saluggia (VC) Italy Mfd. By: DiaSorin S.p.A UK Branch - Central Road, Dartford, DA1, 5LR, United Kingdom
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Italy
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01 April 2022
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10 February 2027
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View |
IVDR-00556A
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ATELLICA™ IM HIV Ag/Ab COMBO ENHANCED (CHIV) ASSAY
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Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics, Inc. - Massachusetts, USA For Siemens Healthcare Diagnostic, Inc. - New York, USA
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USA
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10 February 2021
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10 February 2022
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