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IVDR-00217
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AUTOBIO HBSAG ELISA VERSION 1
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Autobio Diagnostic Co., Ltd.
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China
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24 April 2018
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22 August 2022
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IVDR-00218
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Autobio HIV ELISA
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Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, National Eco & Tech Development Arera 450016 Zhengzhou, People's Republic of China
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China
|
04 April 2023
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22 August 2027
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IVDR-00219
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ABON BZO ONE STEP DRUG SCREEN TEST DEVICE (URINE)
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Abon Biopharm (Hangzhou) Co., Ltd.
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China
|
02 January 2020
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22 August 2022
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IVDR-00220
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ABON MDMA ONE STEP ECSTACY TEST DEVICE (URINE)
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Abon Biopharm (Hangzhou) Co., Ltd.
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China
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02 January 2020
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22 August 2022
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| View |
IVDR-00221
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Autobio ANTI-HCV ELISA VERSION 1
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Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, national Eco & Tech Development Area 450016 Zhengzhou, People's Republic of China
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China
|
23 May 2023
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22 August 2027
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| View |
IVDR-00225
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ADVIA CENTAUR HBsAg II (HBsII) READY PACK
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Siemens Healthcare GmbH
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USA
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02 January 2020
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31 August 2022
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| View |
IVDR-00226
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ADVANCED QUALITY™ ONE STEP ANTI-TP (TREPONEMA PALLIDUM/SYPHILIS)
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Intec Products, Inc.
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China
|
15 December 2017
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31 August 2022
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| View |
IVDR-00227
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HISCL™ Anti-TP Calibrator
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Sysmex Asia Pacific 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
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Japan
|
16 June 2022
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31 August 2027
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| View |
IVDR-00228
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DG GEL T/S POLY
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Grifols International S.A.
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Spain
|
22 May 2018
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13 September 2022
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| View |
IVDR-00229
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Bioquick Pregnancy Test Kit - Cassette
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Nantong Egens Biotechnology Co., Ltd. Bldg. 15, Bldg. 12 (west) No. 1692 Xinghu Ave., Nantong Economy & Technolgy Development Zone 226010 Nantong, Jiangsu, P.R. China
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China
|
27 April 2023
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13 September 2027
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| View |
IVDR-00230
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HISCL HIV Ag + AG Control
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Sysmex Asia Pacific Pte. Ltd. 9 Tampines Grande, #06-18 Singapore Mfd. By: Sysmex Corporation 1-5-1 Wakinohoma-Kaigandori Chou-Ku, Kobe, Japan
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Singapore
|
17 January 2023
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13 September 2027
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| View |
IVDR-00231
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ADVANCED HBsAg ELISA TEST KIT
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Intec Products Inc.
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China
|
28 May 2017
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13 September 2022
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| View |
IVDR-00232
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Quick Profile™ Syphilis Antibody Test Card
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LumiQuick Diagnostics, Inc. 2946 Scott Blvd., Santa Clara, California, 95054, USA Mfd. By: Xiamen Boson Biotech Co., Ltd. - Fujian, P.R. China
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USA
|
31 January 2023
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13 September 2027
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| View |
IVDR-00234
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Bioline™ HCV Multi Device
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Allied Diagnostics Korea Inc. 65, Borahagal-ro, Gihueng-gu, Yongin-si, Gyeonggi-do 17099, Republic of Korea
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Korea
|
04 November 2022
|
13 September 2027
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| View |
IVDR-00235A
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ACCESS HBsAb TEST REAGENT (IVD)
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Beckman Coultre Pte. Ltd.
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Singapore
|
02 April 2018
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13 September 2022
|
| View |
IVDR-00235B
|
ACCESS HBsAb CALIBRATOR
|
Beckman Coultre Pte. Ltd.
|
Singapore
|
02 April 2018
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13 September 2022
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| View |
IVDR-00235C
|
ACCESS HBsAb CONTROL
|
Beckman Coultre Pte. Ltd.
|
Singapore
|
02 April 2018
|
13 September 2022
|
| View |
IVDR-00239
|
RANDOX SYPHILIS - TREPONEMA PALLIDUM HAEMAGGLUTINATION ASSAY (SYP-TPHA)
|
Randox Laboratories Ltd.
|
Ireland
|
08 January 2018
|
12 October 2022
|
| View |
IVDR-00240
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ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE
|
Ortho-Clinical Diagnostics
|
USA
|
16 January 2019
|
12 October 2022
|
| View |
IVDR-00241
|
ABON COC ONE STEP COCAINE TEST DEVICE (URINE)
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Abon Biopharm (Hangzhou) Co., Ltd.
|
China
|
02 January 2020
|
03 November 2022
|