| View |
IVDR-00765
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COBAS HCQ Quantitative Nucleic Acid test for use on the Cobas 4800 System
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Roche Molecular System, Inc. - 1080 US Highway 202 South, Branchburg, NJ, USA Mfd by: Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305, Mannheim, Germany
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Germany
|
30 June 2023
|
30 June 2024
|
| View |
IVDR-00766
|
i-STAT Total β-hcg Control Level 1
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Abbott Point of Care Inc. 400 College Road East, NJ 08540, USA MFd By: Abbott Point of Care, Inc. - 100 and 200 Abbott Park Road, Abbott Park, IL 60064, United states of America
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USA
|
11 April 2024
|
30 June 2029
|
| View |
IVDR-00767
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Ecotest®HCG Pregnancy Rapid Test Device for Self Testing Only
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Assure Tech (Hangzhou) Co, Ltd. - 3rd Flr bldg 4, No. 1418-50, Morganshan Road,Hangzhou, Zhejiang, China
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China
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10 July 2023
|
10 July 2024
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| View |
IVDR-00768
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DEEL 5-in-1 Drug Rapid Test Cassette (THC50+MET1000+MDMA500+COC300+OPI2000)
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HangZhou Alltest Biotech Co., Ltd. - 550#, Yinhai Street, Hangzhou Economic and Technolofical Development Area, 310018 Hangzhou, People`s Republic of China
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China
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14 July 2023
|
14 July 2024
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| View |
IVDR-00769
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DEEL 2-in-1 Drug Rapid Test Cassette (MET500/THC50)
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HangZhou Alltest Biotech Co., Ltd. - 550#, Yinhai Street, Hangzhou Economic and Technolofical Development Area, 310018 Hangzhou, People`s Republic of China
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China
|
14 July 2023
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14 July 2024
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| View |
IVDR-00770
|
MAGLUMI® FREE ß-HCG (CLIA)
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Shenzhen New Industries Biomedical Engineering co., Ltd. - No. 23, Jingxiu East Road, Pingshan District 518122 Shenzhen, People`s Republic of China
|
China
|
18 July 2023
|
18 July 2024
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| View |
IVDR-00771
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LIAISON™ MUREX HIV Ab/Ag HT Assay
|
Diasorin S.p.A.- Via Crescentino, snc, 13040 Saluggia (VC), Italy
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Italy
|
28 July 2023
|
28 July 2024
|
| View |
IVDR-00772
|
LIAISON™ MUREX HIV Ab/Ag HT Control
|
Diasorin S.p.A.- Via Crescentino, snc, 13040 Saluggia (VC), Italy
|
Italy
|
28 July 2023
|
28 July 2024
|
| View |
IVDR-00773
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Surgitech hCG One-Step Pregancy Test (Cassette)
|
Hangzhou Sejoy Electronics & Intruments Co, Ltd - No. 365, Wuzhou Road, Yuhang Economic
Development Zone, Hangzhou City, 311100 Zhejiang China
|
China
|
03 August 2023
|
03 August 2024
|
| View |
IVDR-00774
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Acon® hCG Pregnancy Rapid Test Cassette
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Acon Biotech (Hangzhou) Co, Ltd - No. 210 Zhenzhong Road, West Lake District, Hangzhou, P.R
China
|
China
|
08 August 2023
|
08 August 2024
|
| View |
IVDR-00778
|
OnSite® hCG Combo Rapid Test - Cassette
|
CTK Biotech, Inc. 13855 Stowe Dr. Poway, California, 92064 USA
|
USA
|
19 October 2023
|
19 October 2024
|
| View |
IVDR-00779
|
i-STAT Total β-hCG Control Level 2
|
Abbott Point Care, Inc. 400 College Road East, Princeton NJ 08540 USA Mfd By: Abbott Point of Care Inc. - 100 and 200 Abbott Park Road Abbott Park, IL 60064 United States of America
|
USA
|
30 May 2024
|
19 October 2029
|
| View |
IVDR-00783
|
Basechek™ HCG Pregnancy Rapid Test Cassette (Urine/Serum/Plasma)
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Acro Biotech, Inc 4650 Arrow Highway Suite D6 Montclair, CA 91763 Mfd By: Hangzhou AllTest Biotech Co., Ltd. - 550#, Yinhai Street, Hangzhou Economic and Development Area, 310018 Hangzhou, People's Republic of China
|
China
|
03 January 2024
|
03 January 2025
|
| View |
IVDR-00784
|
Advan Evacuated Blood Collection Tube EDTA K2 PET
|
Chengdu Rich Science Industry Vo., Ltd. No. 66, Tianqindong St., West He-Tech Development Zone, Chengdu, China
|
China
|
03 January 2024
|
03 January 2025
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| View |
IVDR-00785
|
Advan Evacuated Blood Collection Tube Sodium Citrate (1:9) PET
|
Chengdu Rich Science Industry Vo., Ltd. No. 66, Tianqindong St., West He-Tech Development Zone, Chengdu, China
|
China
|
03 January 2024
|
03 January 2025
|
| View |
IVDR-00786
|
iFlash free βHCG
|
Shenzhen Yhlo Biotech Co., Ltd. Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, 518116 Shenzhen, People's Republic of China
|
China
|
03 January 2024
|
03 January 2025
|
| View |
IVDR-00787
|
iFlash HCG
|
Shenzhen Yhlo Biotech Co., Ltd. Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, 518116 Shenzhen, People's Republic of China
|
China
|
03 January 2024
|
03 January 2025
|
| View |
IVDR-00789
|
Micro Blood Collection Tube with EDTA K2
|
Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Guangyan 318020 Taizhou, Zhejiang China Mfd By: Zhejiang Gongdong Medical Technology Co., Ltd. - No. 88 Jingxian Road, Huanyan, 318020, Taizhou, Zhejiang, China
|
China
|
31 January 2024
|
19 January 2025
|
| View |
IVDR-00791
|
HIV Antigen and Antibodies to Human Immunodeficiency Virus (CLIA)
|
Shezhen Mindray Bio-medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
|
China
|
08 February 2024
|
08 February 2025
|
| View |
IVDR-00792
|
HBsAg Hepatitis B Surface Antigen (CLIA)
|
Shezhen Mindray Bio-medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
|
China
|
08 February 2024
|
08 February 2025
|