| View |
IVDR-00049
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HCG PREGNANCY TEST - CASSETTE
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Core Technology Co., Ltd.
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China
|
16 March 2020
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14 October 2024
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| View |
IVDR-00052
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ADVIA CENTAUR SYPHILIS ASSAY KIT
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Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - East Walpole, MA, USA For Siemens Healthcare Diagnostics Inc. - Tarrytown, NY, USA
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USA
|
22 February 2021
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23 December 2024
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| View |
IVDR-00053
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ADVIA CENTAUR ANTI-HBS2 (aHBS2) ASSAY READY PACK
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Siemens Healthcare GmbH
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USA
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10 June 2020
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23 December 2024
|
| View |
IVDR-00054
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ADVIA CENTAUR ANTI-HBe (aHBe) ASSAY READY PACK
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Siemens Healthcare GmbH
|
USA
|
10 June 2020
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08 January 2025
|
| View |
IVDR-00055
|
ADVIA CENTAUR HEPATITIS Be ANTIGEN (HBeAg) REAGENT PACK
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Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - East Walpole, MA, USA For Siemens Healthcare Diagnostics Inc. - Tarrytown, NY, USA
|
USA
|
08 April 2021
|
30 March 2025
|
| View |
IVDR-00057
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Procleix® Ultrio Elite™ Assay Positive Calibrator Kit- Nucleic Acid Amplification Test
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Grifols Diagnostics Solutions Inc. 4560 Horton St., Emeryville, CA, USA
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USA
|
04 November 2022
|
08 August 2027
|
| View |
IVDR-00058
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PROCLEIX® ULTRIO ELITE™ ASSAY NEGATIVE CALIBRATORS KIT
|
Grifols Diagnostic Solutions Inc.
|
USA
|
22 May 2020
|
03 February 2025
|
| View |
IVDR-00059
|
PROCLEIX® ULTRIO ELITE™ ASSAY DISCRIMINATORY PROBE REAGENTS NUCLEIC ACID AMPLIFICATION TEST
|
Grifols Diagnostics Solutions Inc.
|
USA
|
21 January 2020
|
03 February 2025
|
| View |
IVDR-00060
|
PROCLEIX® ULTRIO ELITE™ ASSAY MASTER KIT (BOX 1) NUCLEIC ACID AMPLIFICATION TEST
|
Grifols Diagnostics Solutions Inc.
|
USA
|
03 January 2020
|
16 November 2024
|
| View |
IVDR-00060A
|
PROCLEIX® ULTRIO ELITE™ ASSAY TARGET CAPTURE REAGENT - BOX 2
|
Grifols Diagnostic Solutions Inc.
|
USA
|
22 May 2020
|
30 March 2025
|
| View |
IVDR-00060B
|
Procleix® Ultrio Elite™ Assay Selection Reagent (Box 3) Nucleic Acid Amplification Test
|
Grifols Diagnostics Solutions Inc. 4560 Horton St., Emeryville, CA, USA
|
USA
|
04 November 2022
|
08 August 2027
|
| View |
IVDR-00061
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PROCLEIX® ULTRIO ELITE™ ASSAY TARGET ENHANCER REAGENT NUCLEIC ACID AMPLIFICATION TEST
|
Grifols Diagnostic Solutions Inc. - 4560 Horton Street, Emeryville, CA, 94608, USA
|
USA
|
21 October 2020
|
21 October 2021
|
| View |
IVDR-00063
|
ADVIA CENTAUR HIV Ag/Ab COMBO (CHIV) ASSAY READY PACK
|
Siemens Healthcare GmbH
|
USA
|
02 January 2020
|
31 August 2022
|
| View |
IVDR-00064
|
RIGHTSIGN® HCG PREGNANCY RAPID TEST KIT - CASSETTE
|
Hangzhou Biotest Biotech Co., Ltd.
|
China
|
02 November 2019
|
14 February 2025
|
| View |
IVDR-00065
|
RIGHTSIGN® HCG PREGNANCY RAPID TEST KIT - CASSETTE
|
Hangzhou Biotest Biotech Co., Ltd.
|
China
|
14 January 2020
|
17 February 2025
|
| View |
IVDR-000657A
|
Bruner Disposable Vacuum Blood Collection Tube, Plastic, Red Top - Plain
|
Zhejiang Gongdong Medical Technology Co., Ltd. No. 10, Beiyuan Ave., Huangyan, 318020 Taizhou, Zhejiang, People's Republic of China
|
China
|
04 May 2023
|
29 December 2027
|
| View |
IVDR-000657B
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Bruner Disposable Vacuum Blood Collection Tube, Plastic, Red Top - Eith Clot Activator
|
Zhejiang Gongdong Medical Technology Co., Ltd. No. 10, Beiyuan Ave., Huangyan, 318020 Taizhou, Zhejiang, People's Republic of China
|
China
|
04 May 2023
|
29 December 2027
|
| View |
IVDR-000657C
|
Bruner Disposable Vacuum Blood Collection Tube, Plastic, Yellow Top - Eith Clot Activator
|
Zhejiang Gongdong Medical Technology Co., Ltd. No. 10, Beiyuan Ave., Huangyan, 318020 Taizhou, Zhejiang, People's Republic of China
|
China
|
04 May 2023
|
29 December 2027
|
| View |
IVDR-000657D
|
Bruner Disposable Vacuum Blood Collection Tube, Plastic, Lavender Top- EDTA K2
|
Zhejiang Gongdong Medical Technology Co., Ltd. No. 10, Beiyuan Ave., Huangyan, 318020 Taizhou, Zhejiang, People's Republic of China
|
China
|
04 May 2023
|
29 December 2027
|
| View |
IVDR-000657E
|
Bruner Disposable Vacuum Blood Collection Tube, Plastic, Lavender Top- EDTA K3
|
Zhejiang Gongdong Medical Technology Co., Ltd. No. 10, Beiyuan Ave., Huangyan, 318020 Taizhou, Zhejiang, People's Republic of China
|
China
|
04 May 2023
|
29 December 2027
|