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IVDR-00739
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Surestep™ AMP1000 Urine Drug Test Cassette
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Innovacon, Inc. 9975 Summers Ridge Road, San Diego, CA 92121 USA Mfd. By: Abon Biopharm (Hangzhou) Co., Ltd. - #198, 12th Street, East, Hangzhou Economic & Technological Development Area 310018 Hangzhou, People's Republic of China
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USA
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21 February 2023
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21 February 2024
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IVDR-00740
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Surestep™ MDMA 500 Urine Drug Test Cassette
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Innovacon, Inc. 9975 Summers Ridge Road, San Diego, CA 92121 USA Mfd. By: Abon Biopharm (Hangzhou) Co., Ltd. - #198, 12th Street, East, Hangzhou Economic & Technological Development Area 310018 Hangzhou, People's Republic of China
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USA
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21 February 2023
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21 February 2024
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IVDR-00741
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Cobas® HBV for use on the Cobas 4800 System
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Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 088876, USA
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USA
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17 March 2023
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17 March 2024
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IVDR-00741A
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Cobas® HBV/HCV/HIV-1 Control Kit
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Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany Mfd. By: Roche Molecular Systems, Inc. -1080 USA Highway 202 South, Branchburg, New Jersey, USA
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USA
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11 May 2023
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28 April 2024
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IVDR-00742
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Lifecheck One Step HCG Urine/Serum Test
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Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China
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China
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17 March 2023
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17 March 2024
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| View |
IVDR-00743
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Siny® Vacuum Blood Collection Tube (EDTA-K2) PET Tube
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Anhui Sinic Laboratory Medicine Technology Co., Ltd. No. 2, Dongyi North Road, Economic & Technology Zone, Tongcheng, anhui, People's Republic of China
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China
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17 March 2023
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17 March 2024
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| View |
IVDR-00744
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Siny® Vacuum Blood Collection Tube (EDTA-K3) PET Tube
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Anhui Sinic Laboratory Medicine Technology Co., Ltd. No. 2, Dongyi North Road, Economic & Technology Zone, Tongcheng, anhui, People's Republic of China
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China
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17 March 2023
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17 March 2024
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| View |
IVDR-00745
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Siny® Vacuum Blood Collection Tube (No Additive) PET Tube
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Anhui Sinic Laboratory Medicine Technology Co., Ltd. No. 2, Dongyi North Road, Economic & Technology Zone, Tongcheng, anhui, People's Republic of China
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China
|
17 March 2023
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17 March 2024
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| View |
IVDR-00746
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Siny® Vacuum Blood Collection Tube (3.2% Sodium Citrate) PET Tube
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Anhui Sinic Laboratory Medicine Technology Co., Ltd. No. 2, Dongyi North Road, Economic & Technology Zone, Tongcheng, anhui, People's Republic of China
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China
|
17 March 2023
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17 March 2024
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| View |
IVDR-00747
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Siny® Vacuum Blood Collection Tube (Gel & Clot Activator) PET Tube
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Anhui Sinic Laboratory Medicine Technology Co., Ltd. No. 2, Dongyi North Road, Economic & Technology Zone, Tongcheng, anhui, People's Republic of China
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China
|
17 March 2023
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17 March 2024
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| View |
IVDR-00748
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Cobas HIV - 1 Quantitative nucleic acid test for the use on the Cobas 4800 System
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Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, New Jersey, 08876 USA
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USA
|
22 March 2023
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24 March 2024
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| View |
IVDR-00749A
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ST AIA-PACK HBsAg Reagent
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Tosoh Corporation 4560 Kaisei-cho, Shunan, Yamaguchi 746-8501, Japan Mfd. By: Tosoh AIA, Inc. - 2, Iwasekoshi-machi, Toyama, Japan For: Tosoh Corporation -Shiba-KoenTosoh Corporation - Shiba-Koen First Building 3-8-2, Shiba, Manato-Ku, Tokyo 105-8623 Japan
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Japan
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24 March 2023
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24 March 2024
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| View |
IVDR-00749B
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AIA-PACK HBsAg Calibrator Set
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Tosoh Corporation 4560 Kaisei-cho, Shunan, Yamaguchi 746-8501, Japan Mfd. By: Tosoh AIA, Inc. - 2, Iwasekoshi-machi, Toyama, Japan For: Tosoh Corporation -Shiba-KoenTosoh Corporation - Shiba-Koen First Building 3-8-2, Shiba, Manato-Ku, Tokyo 105-8623 Japan
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Japan
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24 March 2023
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24 March 2024
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| View |
IVDR-00749C
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AIA-PACK HBsAg Antigen Control Set
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Tosoh Corporation 4560 Kaisei-cho, Shunan, Yamaguchi 746-8501, Japan Mfd. By: Tosoh AIA, Inc. - 2, Iwasekoshi-machi, Toyama, Japan For: Tosoh Corporation -Shiba-KoenTosoh Corporation - Shiba-Koen First Building 3-8-2, Shiba, Manato-Ku, Tokyo 105-8623 Japan
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Japan
|
24 March 2023
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24 March 2024
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| View |
IVDR-00750A
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ST AIA-PACK HBsAb Reagent
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Tosoh Corporation 4560 Kaisei-cho, Shunan, Yamaguchi 746-8501, Japan Mfd. By: Tosoh AIA, Inc. - 2, Iwasekoshi-machi, Toyama, Japan For: Tosoh Corporation -Shiba-KoenTosoh Corporation - Shiba-Koen First Building 3-8-2, Shiba, Manato-Ku, Tokyo 105-8623 Japan
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Japan
|
24 March 2023
|
24 March 2024
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| View |
IVDR-00750B
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AIA-PACK HBsAb Calibrator Set
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Tosoh Corporation 4560 Kaisei-cho, Shunan, Yamaguchi 746-8501, Japan Mfd. By: Tosoh AIA, Inc. - 2, Iwasekoshi-machi, Toyama, Japan For: Tosoh Corporation -Shiba-KoenTosoh Corporation - Shiba-Koen First Building 3-8-2, Shiba, Manato-Ku, Tokyo 105-8623 Japan
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Japan
|
24 March 2023
|
24 March 2024
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| View |
IVDR-00750C
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AIA-PACK HBsAb Antibody Control Set
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Tosoh Corporation 4560 Kaisei-cho, Shunan, Yamaguchi 746-8501, Japan Mfd. By: Tosoh AIA, Inc. - 2, Iwasekoshi-machi, Toyama, Japan For: Tosoh Corporation -Shiba-KoenTosoh Corporation - Shiba-Koen First Building 3-8-2, Shiba, Manato-Ku, Tokyo 105-8623 Japan
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Japan
|
24 March 2023
|
24 March 2024
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| View |
IVDR-00751
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Acon® hCG Pregnancy Rapid Test Strip (Urine)
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Acon Biotech (Hangzhou) Co., Ltd. No. 210 Zhenzhong Road, West Lake District 310030 Hangzhou, People's Republic of China
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China
|
30 March 2023
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30 March 2024
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| View |
IVDR-00752
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Vacugen™ Micro EDTA Tube
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Baoding Beifansi Medical Device Technology Co., Ltd. No. 70 West Road Chaoyang, Yixian, Baoding, Hebei, China
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China
|
30 March 2023
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30 March 2024
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| View |
IVDR-00753
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Micro Blood Collection Tube - Plain (PET)
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Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Huangyan 318020 Taizhou, Zhejiang, People's Republic of China
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China
|
15 May 2024
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05 April 2029
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