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IVDR-00556B
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ATELLICA™ IM HIV Ag/Ab COMBO QUALITY CONTROL (CHIV QC)
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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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IVDR-00557
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Meriscreen Syphiline one Step test for Syphilis
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Meril Diagnostics Pvt. Ltd.- Second Floor, D1-D3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396 191, Gujarat, India
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India
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03 February 2022
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10 February 2027
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IVDR-00558A
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Liaison® HBc IgM Assay Kit
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DIASORIN S.p.A. via Crescentino, snc, 13040 Saluggia (VC) Italy
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Italy
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28 September 2022
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16 February 2027
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IVDR-00558B
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Liaison® Control HBc IgM HBV Control Kit
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DIASORIN S.p.A. via Crescentino, snc, 13040 Saluggia (VC) Italy
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Italy
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28 September 2022
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16 February 2027
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IVDR-00559
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BIOEASY ONE STEP ANTI TP RAPID TEST
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Shezhen Bioeasy Biotechnology Co., Ltd. - Guangdong Province, China
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China
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18 February 2021
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18 February 2022
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IVDR-00560
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iScreen Syphilis Ab Rapid Test Cassette (Whole Blood/ Serum/ Plasma)
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Zhejiang Orient Gene Biotech Co., Ltd.- 3787#, East Yangguang Avenue, Dipu Street Anji, 313300 Huzhou, Zhejiang, People's Republic of China
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China
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27 December 2021
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18 February 2027
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IVDR-00561
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JUSCHEK HCG PREGNANCY ENHANCED SENSITIVITY RAPID TEST DIPSTICK (SERUM/PLASMA/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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18 February 2021
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18 February 2022
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IVDR-00562
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CAPTIA™ SYPHILIS TA EIA
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Trinity Biotech Manufacturing Limited - Wicklow, Ireland mfd. By: Trinity Biotech USA - New York, USA
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USA
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18 February 2021
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18 February 2022
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IVDR-00563
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Eryclone Anti-Human Globulin
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Tulip Diagnostics (P) Ltd and Coral Clinical Systems(A Division of Tulip Diagnostics (P) Ltd.) Goa, India Mfd. By: Tulip Diagnostics (P) Ltd.-Goa, India
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India
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28 September 2022
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18 February 2027
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IVDR-00564A
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LIAISON® XL MUREX ANTI-HBS HBV ASSAY
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Diasorin S.p.A. - Via Crescentino, snc 13040 Saluggia (VC), Italy
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Italy
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03 March 2021
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03 March 2022
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IVDR-00564B
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LIAISON® XL MUREX CONTROL ANTI-HBS HBV CONTROL
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Diasorin S.p.A. - Via Crescentino, snc 13040 Saluggia (VC), Italy
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Italy
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03 March 2021
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03 March 2022
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IVDR-00565
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One Step hCG Pregnancy Test
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Kenxin International Co., Ltd. - Rm. 714 Huagang Office Building, No. 140 Zhongshandadao, Guangzhou, China
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China
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17 August 2022
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03 March 2027
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IVDR-00566
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SPECICHEK HCG TEST DEVICE (Rapid test for qualitative detection of HCG in human urine - One step HCG Pregnancy detection test device)
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Pandix Healthcare LLP - Delhi, India mfd. By: Oscar Medicare Pvt. Ltd. - New Delhi, India
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India
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29 March 2021
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29 March 2022
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IVDR-00567
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Determine™ HIV Controls & p24 Ag Control
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Abbott Diagnostics Medical Co., Ltd. - 357 Matsuhidai, Matsudo-shi, Chiba, 270-2214, Japan
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Japan
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30 August 2022
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08 April 2027
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IVDR-00568
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GEENIUS™ HIV - 1/2 COMFIRMATORY CONTROL
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Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad - Marnes La Coquette France
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Singapore
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29 March 2021
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29 March 2022
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IVDR-00569
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Rapiquick hCG (Human Chorionic Gonadotropin) Pregnancy Rapid Test
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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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27 April 2023
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19 April 2027
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IVDR-00570
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Bio-Rad Syphilis Total Ab Kit Anti-Treponema EIA Screen
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Bio-Rad Laboratories (Singapore) Pte. Ltd - 3A International Business Park #11-10/16, ICON@IBP Tower B, Singapore 609925
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Singapore
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10 August 2022
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19 April 2027
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IVDR-00571
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Bioline™ HCV One Step Anti0HCV Test
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Abott Diagnostics Korea Inc. - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
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Korea
|
10 August 2022
|
21 May 2027
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IVDR-00572
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STANDARD™ Q SYPHILIS AB TEST
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SD Biosensor, Inc. - Gyeonggi-do, Republic of Kore mfd. By: SD Biosensor, Inc. - Chungcheongbuk-do, Republic of Korea
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Korea
|
30 April 2021
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30 April 2022
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IVDR-00573
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ONLINE DAT BENZODIAZEPINES II
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Roche Diagnostics GmbH - Mannheim, Germany
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Germany
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30 April 2021
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30 April 2022
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