| View |
IVDR-00503
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iScreen Hepatitis C Virus HCV Ab Rapid Test Cassette (Serum/Plasma)
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Zhejiang Orient Gene Biotech Co., Ltd. - Zhejiang, China
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China
|
08 March 2022
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16 June 2026
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| View |
IVDR-00504
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SURE-CHECK® HIV 1/2 ASSAY
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Chembio Diagnostic Systems, Inc.
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USA
|
17 June 2020
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17 June 2021
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| View |
IVDR-00505
|
Sure-Guard Pregnancy Test Kit
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Nantong Egens Biotechnology Co., Ltd. - Nantong, People's Republic of China
|
China
|
06 April 2022
|
26 June 2026
|
| View |
IVDR-00506
|
Medic Pregnancy Test Kit
|
Nantong Egens Biotechnology Co., Ltd. - Nantong, People's Republic of China
|
China
|
06 April 2022
|
26 June 2026
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| View |
IVDR-00507
|
BASECHECK™ PREGNANCY (hCG) RAPID TEST CASSETTE
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Acro Biotech Inc. - Rancho Cucamonga, CA, U.S.A mfd. By: Hangzhou All Test Biotech Co., Ltd. - Hangzhou, PR China
|
China
|
20 September 2021
|
26 June 2026
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| View |
IVDR-00508A
|
ELECSYS HCG STAT TEST KIT
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Roche Diagnostic GmbH
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Germany
|
02 July 2020
|
02 July 2021
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| View |
IVDR-00508B
|
HCG STAT CALSET STAT TEST KIT
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Roche Diagnostic GmbH
|
Germany
|
02 July 2020
|
02 July 2021
|
| View |
IVDR-00509
|
VITROLOL III® UNASSAYED (HUMAN) SEROLOGY CONTROL
|
Bio-rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-rad Laboratories - Irvine, CA, USA
|
USA
|
17 August 2021
|
02 July 2026
|
| View |
IVDR-00510
|
Sure-Guard Pregnancy Test Kit
|
Hangzhou AllTest Biotech Co., Ltd. - 550#, Yinhai Street, Hangzhou economic and Technological Development Area 310018 Hangzhou, People's Republic of China
|
China
|
30 August 2022
|
23 July 2026
|
| View |
IVDR-00511A
|
LIAISON® ANTI-HBC
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Diasorin S.p.A. - Via Cresentino snc, 13040 Saluggia (VC), Italy
|
Italy
|
09 July 2021
|
30 July 2026
|
| View |
IVDR-00511B
|
LIAISON® ANTI-HBC CONTROL
|
Diasorin S.p.A. - Via Cresentino snc, 13040 Saluggia (VC), Italy
|
Italy
|
09 July 2021
|
30 July 2026
|
| View |
IVDR-00512
|
Immunoclone® RH-HR Control
|
Immucor, Inc. Nocross, Georgia, USA Mfd. By: Millipore Corporation - West Lothian, UK For: Immucor Medizinische Diagnostik GmbH - Dreieich, Germany
|
Germany
|
20 April 2023
|
29 October 2027
|
| View |
IVDR-00513A
|
LIAISON® HBeAg
|
Diasorin S.p.A. - Via Crescentino, Saluggia (VC), Italy
|
Italy
|
20 September 2021
|
17 August 2026
|
| View |
IVDR-00513B
|
LIAISON® CONTROL HBeAg
|
Diasorin S.p.A. - Via Crescentino, Saluggia (VC), Italy
|
Italy
|
20 September 2021
|
17 August 2026
|
| View |
IVDR-00515
|
VIDAS ANTI-HBs TOTAL II
|
Biomerieux S.A.
|
France
|
22 September 2020
|
22 September 2021
|
| View |
IVDR-00516
|
NEWBIO TPHA TEST KIT
|
Newmark Biomedical Ltd.
|
United Kingdom
|
22 September 2020
|
22 September 2021
|
| View |
IVDR-00517
|
BASECHECK™ LEPTOSPIRA IgG/IgM RAPID TEST CASSETTE
|
Acro Biotech Inc. - Rancho Cucamonga, CA, U.S.A mfd. By: Hangzhou All Test Biotech Co., Ltd. - Hangzhou, PR China
|
China
|
16 September 2021
|
23 September 2026
|
| View |
IVDR-00518
|
Elecsys HBsAg Confirmatory Test
|
Roche Diagnotics GmbH-Sandhofer Strasse 116 68305 Mannheim, Germany
|
Gemany
|
08 February 2022
|
23 September 2026
|
| View |
IVDR-00519
|
Leptocheck WB Device Test for IgM Antibodies to Leptospira
|
Tulip Diagnostics (P) Ltd and Coral Clinic Systems (A Division of Tulip Diagnostics (P) Ltd - Goa, India mfd. By: Zephyr Biomedical - A Division of Tulip Diagnostics (P) Ltd - Goa, India
|
India
|
28 April 2022
|
20 October 2026
|
| View |
IVDR-00520
|
Sysmex Hiscl™ Anit-HCV Calibrator
|
Sysmex Asia Pacific Pte. Ltd. 9 Tampines Grande, #06-18 Singapore Mfd. By: Sysmex Corporation - Seishin Factory 4-3-2 Takatsukadai, Nish-Ku, Kobe Hyogo, Japan For: Sysmex Corporation - 1-5-1 Wakinohoma-Kaigandori Chou-Ku, Kobe, 651-0073 Japan
|
Singapore
|
17 January 2023
|
13 January 2028
|