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IDVR-00540
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Clungene® HCG Pregnancy Rapid Test Cassette
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Hangzhou Clongene Biotech C. Ltd. - No. 1 Yichuang Sub-district 311121 Hangzhou P.R. China
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China
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18 July 2022
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29 December 2026
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IVD-00141
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HISCL HIVAg + Ab Calibrator
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Sysmex Asia Pacific Pte. Ltd.- Singapore Mfd. By: Sysmex International Reagents Co., Ltd., (Seishin Factory) - Kobe Hyogo, Japan for Sysmex Corp.- Kobe, Japan
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Singapore
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08 February 2022
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27 August 2026
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IVD-00621
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DG Gel Anit-IgG
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Grifols International, S.A. Poligno Levante, Calle Can Guasch, s/n 08150, Parets del Valles, Barcelona, Spain Mfd. By: Diagnostic Grifols S.A. - Passeig Fluvial, 24 Parets del Valles Barcelona, Spain
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Spain
|
28 February 2023
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12 August 2027
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IVDR-00002
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EM-3 HCG Serum Cassette Pregnancy Test Kit
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Nantong Egens Biotechnology Co., Ltd. Building 15, Building 12 (West), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone, Jiangsu Province, China
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China
|
29 May 2024
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09 May 2028
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IVDR-00005
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EM-3 HCG Urine/Serum Pregnancy Test Strip
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Nantong Egens Biotechnology Co., Ltd. Building 15, Building 12 (West), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone, Jiangsu Province, China
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China
|
28 May 2024
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28 June 2028
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IVDR-00006
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EM-3 HCG URINE PREGNANCY TEST STRIP
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Nantong Egens Biotechnology Co., Ltd.
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China
|
19 November 2018
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03 July 2023
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IVDR-00014
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LABOQUICK PREGNANCY TEST KIT - CASSETTE
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Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
|
Turkey
|
27 May 2019
|
31 July 2023
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IVDR-00015
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ACCESS® HIV COMBO REAGENT
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Bio-rad Laboratories (Singapore) Pte. Ltd.
|
France
|
03 December 2018
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31 July 2023
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IVDR-00016
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SOOBN ONE STEP PREGNANCY TEST KIT - CASSETTE
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Hangzhou Clongene Biotech Co., Ltd.
|
China
|
16 January 2019
|
02 August 2023
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IVDR-00019
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SD BIOLINE ONE STEP PREGNANCY TES KIT - URINE/SERUM
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Standard Diagnostics, Inc.
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Korea
|
09 July 2019
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05 October 2023
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IVDR-00020
|
Access® HIV Combo Calibrator
|
Bio-Rad Laboratories (Singapore) Pte. Ltd. 3A International Business Park #11 - 10//16, ICON@IBP Tower B, Singapore 609935 Mfd. By: Bio-Rad-3 boulevard Raymond Pioncare 92430 Marnes-La-Coquette France
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Singapre
|
23 May 2023
|
05 October 2028
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IVDR-00021
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ACCESS® HIV COMBO QC REAGENT
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Bio-rad Laboratories (Singapore) Pte. Ltd.
|
France
|
26 March 2019
|
14 February 2024
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IVDR-00024
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ACCUCARE ANTI-B MONOCLONAL (IgM) BLOOD GROUPING SERA
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Lab Care Diagnostics (India) Pvt. Ltd. 16A, 'A' Wing, Sita Estate, 1st Floor, Aziz Baug, Mahul Raod, Chembur, Mumbai-400 074 India Mfd by: LAB-CARE DIAGNOSTICS (INDIA) PVT. LTD.- C1 TYPE, SHED NO. 3225, CHEMICAL ZONE, G.I.D.C. SARIGAM, V ALSAD, GUJARAT, INDIA
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India
|
28 May 2024
|
22 April 2029
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IVDR-00026
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ACCUCARE ANTI-A MONOCLONAL (IgM) BLOOD GROUPING SERA
|
Lab Care Diagnostics (India) Pvt. Ltd. 16A, 'A' Wing, Sita Estate, 1st Floor, Aziz Baug, Mahul Raod, Chembur, Mumbai-400 074 India Mfd by: LAB-CARE DIAGNOSTICS (INDIA) PVT. LTD.- C1 TYPE, SHED NO. 3225, CHEMICAL ZONE, G.I.D.C. SARIGAM, V ALSAD, GUJARAT, INDIA
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India
|
28 May 2024
|
25 April 2029
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IVDR-00028
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ACCUCARE ANTI-D MONOCLONAL (IgM) BLOOD GROUPING SERA
|
Lab Care Diagnostics (India) Pvt. Ltd. 16A, 'A' Wing, Sita Estate, 1st Floor, Aziz Baug, Mahul Raod, Chembur, Mumbai-400 074 India Mfd by: LAB-CARE DIAGNOSTICS (INDIA) PVT. LTD.- C1 TYPE, SHED NO. 3225, CHEMICAL ZONE, G.I.D.C. SARIGAM, V ALSAD, GUJARAT, INDIA
|
India
|
28 May 2024
|
24 April 2029
|
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IVDR-00029
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Immucor Anti B series 3 (Murine Monoclonal) Typing Sera
|
Immucor Inc. 3130 Gateway Drive, Norcross, Georgia USA
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USA
|
22 May 2024
|
22 April 2029
|
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IVDR-00035
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ADVAN PREGNANCY TEST KIT
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Hangzhou Clongene Biotech Co., Ltd.
|
China
|
02 January 2020
|
23 July 2024
|
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IVDR-00037
|
BE SURE ONE STEP PREGNANCY TEST KIT
|
VicTorch Meditek Inc. - CA, USA
|
USA
|
22 March 2021
|
26 July 2024
|
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IVDR-00045
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ABON PREGNANCY TEST DEVICE (URINE/SERUM)
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Abon Biopharm (Hangzhou) Co., Ltd.
|
China
|
14 March 2018
|
20 January 2023
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IVDR-00047
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ABON PREGNANCY TEST URINE DEVICE-CASSETTE
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Abon Biopharm (Hangzhou) Co., Ltd.
|
China
|
14 March 2018
|
20 January 2023
|