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IVDR-00108
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DIACLON® ID CARD FOR ABD CONFIRMATION FOR PATIENTS
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Bio-Rad Laboratories (Sinagpore) Pte. Ltd. - 27 International Business Park #01-02, iQuest@IBP, Singapore 609924 mfd. By: DiaMed Holding GmbH - Pra Rond 23, 1785 Cressier FR, Switzerland
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Switzerland
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12 May 2021
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26 November 2025
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| View |
IVDR-00109
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DIACLON® ID CARD TYPE + SCREEN
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Bio-Rad Laboratories (Sinagpore) Pte. Ltd. - 27 International Business Park #01-02, iQuest@IBP, Singapore 609924 mfd. By: DiaMed Holding GmbH - Pra Rond 23, 1785 Cressier FR, Switzerland
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Switzerland
|
27 April 2021
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28 November 2025
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| View |
IVDR-00110
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DIACLON ® ID CARD COMPLETE CROSSMATCH
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Bio-Rad Laboratories (Singapore) Pte. Ltd. - 27 International Business Park #01-02, iQuest@IBP, Singapore 609924 mfd. By: DiaMed Holding GmbH - Pra Rond 23, 1785 Cressier FR, Switzerland
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Switzerland
|
25 November 2020
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28 November 2025
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| View |
IVDR-00111A
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ARCHITECT ANTI-HCV REAGENT KIT
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Abbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany mfd. By: Abbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany
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Germany
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16 June 2021
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03 December 2025
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| View |
IVDR-00111B
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ARCHITECT ANTI-HCV CALIBRATOR
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Abbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany mfd. By: Abbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany
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Germany
|
16 June 2021
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03 December 2025
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| View |
IVDR-00111C
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ARCHITECT ANTI-HCV CONTROL
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Abbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany mfd. By: Abbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany
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Germany
|
16 June 2021
|
03 December 2025
|
| View |
IVDR-00113
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DIACLON® ID CARD FOR ABD CONFIRMATION FOR DONORS
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Bio-Rad Laboratories (Sinagpore) Pte. Ltd. - 27 International Business Park #01-02, iQuest@IBP, Singapore 609924 mfd. By: DiaMed Holding GmbH - Pra Rond 23, 1785 Cressier FR, Switzerland
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Switzerland
|
27 April 2021
|
26 November 2025
|
| View |
IVDR-00113A
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Architect HIV Ag/Ab Combo Reagent Kit
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Abbott GmbH Max-Planck-Ring 2, 65205, Wiesbaden, Germany
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Germany
|
20 April 2023
|
04 December 2025
|
| View |
IVDR-00113B
|
Architect HIV Ag/Ab Combo Calibrator
|
Abbott GmbH Max-Planck-Ring 2, 65205, Wiesbaden, Germany
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Germany
|
20 April 2023
|
04 December 2025
|
| View |
IVDR-00113C
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Architect HIV Ag/Ab Combo Control
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Abbott GmbH Max-Planck-Ring 2, 65205, Wiesbaden, Germany
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Germany
|
20 April 2023
|
04 December 2025
|
| View |
IVDR-00114A
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ARCHITECT SYPHILIS TP REAGENT KIT
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Abbott GmbH & Co.
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Germany
|
25 August 2016
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07 October 2020
|
| View |
IVDR-00114B
|
ARCHITECT SYPHILIS TP CALIBRATOR
|
Abbott GmbH & Co.
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Germany
|
25 August 2016
|
07 October 2020
|
| View |
IVDR-00114C
|
ARCHITECT SYPHILIS TP CONTROLS
|
Abbott GmbH & Co.
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Germany
|
25 August 2016
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07 October 2020
|
| View |
IVDR-00115
|
Epiclone™ Anti-AB Monoclonal Grouping Reagent
|
Immulab Pty. Ltd. - 63 Poplar Road, Parkville, Victoria 3052 Australia
|
Australia
|
10 August 2022
|
29 October 2026
|
| View |
IVDR-00116
|
RIGHTSIGN™ MDMA RAPID TEST KIT CASSETTE
|
Hangzhou Biotest Biotech Co., Ltd. - Hangzhou, P.R. China
|
China
|
20 September 2021
|
12 February 2026
|
| View |
IVDR-00117
|
RIGHTSIGN® COC RAPID TEST KIT CASSETTE (URINE)
|
Hangzhou BioTest Biotech Co., Ltd. - Yuhang District, Hangzhou, People's Republic of China
|
China
|
12 May 2021
|
11 March 2026
|
| View |
IVDR-00119
|
SYSMEX HISCL™ HBsAg ASSAY KIT
|
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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Japan
|
23 July 2021
|
07 April 2026
|
| View |
IVDR-00120
|
SYSMEX HISCL™ HIV Ag + Ab ASSAY KIT
|
Sysmex Asia Pacific Pte. Ltd. - Singapore mfd. By: Sysmex International Reagents Co., Ltd. - (Seishin Factory) - Kobe Hyogo, Japan For Sysmex Corp. - Kobe, Japan
|
Japan
|
23 July 2021
|
08 April 2026
|
| View |
IVDR-00121
|
ACCUPOINT MIDSTREAM PREGNANCY TEST
|
Victorch Meditek Inc. - CA, USA
|
USA
|
16 July 2021
|
29 April 2026
|
| View |
IVDR-00122
|
BLUE SCREEN SYPHILIS ULTRA RAPID TEST DEVICE
|
Abon Biopharm (Hangzhou) Co., Ltd.
|
China
|
24 May 2017
|
06 May 2021
|