| View |
IVDR-00840
|
Advan Micro Blood Collection Tube (gel & Clot Activator)
|
Chengdu Rich Science Industry Co., Ltd. No. 66, Tianqindong, West Hi-Tech Development Zone, chengdu, China
|
China
|
13 May 2024
|
13 May 2025
|
| View |
IVDR-00841
|
Elecsys Anti-HCV II
|
Roche Diagnpstics GmbH Sandhofer Strasse 116, 68305 Mannheim Germany
|
Germany
|
16 May 2024
|
16 May 2025
|
| View |
IVDR-00842
|
Medasia Medical Products Corporation
|
Hangzhou Clongene Biotech Co., Ltd. No. 1 Yichaung Road, Yuhang Sub-District, Yuhang District, 311121 Hangzhou, P.R. China
|
China
|
28 May 2024
|
28 May 2025
|
| View |
IVDR-00843
|
Juschek Multi-Drug 2 Drugs Rapid Test Cassette (Urine) - MET 1000/THC50)
|
Acro Biotech, Inc. 9500 7th Street, Unit M, Rancho Cucamonga, CA 91730 USA
|
USA
|
22 May 2024
|
22 May 2025
|
| View |
IVDR-00844
|
MYLAN HIV SELF-TEST
|
Mylan Laboratories Limited Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyberabad - 500096, India Mfd By: Lateral Flow Laboratories Pty. Ltd. - unit 1-2, Greenwich place, Capricorn Crescent, Capricorn Business Park, Muizenberg 7540 South Africa For: Atomo Diagnostics Ltd. - Level 1,3-5 George Street, Leichhardt, New South Wales 2024 Australia
|
India
|
17 May 2024
|
17 May 2029
|
| View |
IVDR-00845
|
Mindray Medical International Philippines, Inc.
|
Shezhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, 518057 Shenzhen, People's Republic of China Mfd by: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - 1023 Nanhuan Avenue, Guangming District, 518106 Shenzheh, People's Republic of China
|
China
|
27 May 2024
|
27 May 2025
|
| View |
IVDR-00846
|
Mindray Medical International Philippines, Inc.
|
Shezhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, 518057 Shenzhen, People's Republic of China Mfd by: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - 1023 Nanhuan Avenue, Guangming District, 518106 Shenzheh, People's Republic of China
|
China
|
27 May 2024
|
27 May 2025
|
| View |
IVDR-00848
|
Elecsys HBsAg Confirmatory Test kit
|
Roche Diagnostics GmbH Sandhofer Strasse 116, 68305 Mannheim, Germany
|
Germany
|
07 June 2024
|
29 May 2025
|
| View |
IVDR-00849
|
Autobio Anti-RP CLIA Microparticles Immunoassay
|
Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, National Eco & Tech Development Area, 450016 Zhengzhou, China
|
China
|
29 May 2024
|
29 May 2029
|
| View |
IVDR-00850
|
Truenat® LTS Chip-based Real Time PCR Test for Leptospira
|
M/s. Molbio Diagnostics Pvt. Ltd. Plot No. L-46, Phase II D, Verna Industrial Estate, Verna South Goa, India
|
India
|
29 May 2024
|
29 May 2029
|
| View |
IVDR-00851
|
Truenat® LTS Chip=Based Real Time PCR Test for Leptospira
|
Molbio Diagnostics Pvt. Ltd. Plot No. L-46, Phase II D, Verna Industrial Estate, South Goa, India Mfd By: Molbio Diagnostic Private Limited - Plot No. L-42 Phase II B, Verna Industrial Estae, Vena Goa, India
|
India
|
06 June 2024
|
29 May 2025
|
| View |
IVDR-00852
|
Autobio Anti-HBC CLIA Microparticles Immunoassay
|
Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, National Eco & Tech Development Area, 450016 Zhengzhou, China Mfd By: Autobio Diagnostics Co., Ltd. - no. 199, 15th Ave., National Eco & tech Zone, 450016, Zhenzhou, China
|
China
|
29 May 2024
|
29 May 2025
|
| View |
IVDR-00853
|
Autobio Anti-HBe CLIA Microparticles Immunoassay
|
Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, National Eco & Tech Development Area, 450016 Zhengzhou, China Mfd By: Autobio Diagnostics Co., Ltd. - no. 199, 15th Ave., National Eco & tech Zone, 450016, Zhenzhou, China
|
China
|
29 May 2024
|
29 May 2025
|
| View |
IVDR-00854
|
Autobio Anti-HBs CLIA Microparticles Immunoassay
|
Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, National Eco & Tech Development Area, 450016 Zhengzhou, China Mfd By: Autobio Diagnostics Co., Ltd. - no. 199, 15th Ave., National Eco & tech Zone, 450016, Zhenzhou, China
|
China
|
29 May 2024
|
29 May 2025
|
| View |
IVDR-00855
|
BUNNEWS Early Pregnancy Pregnancy Detection Test One step hCG Test (cassette)
|
Stratgen Healthcare Pvt. Ltd. KSHITIJ Film City Road Goregaon East Mumbai - 400 063 India Mfd by: Oscar Medicare Pvt. Ltd. - E-92, Bahadrabad Industrial Area, Haridwar, Hridwar Uttarkkhand, India
|
India
|
05 June 2024
|
05 June 2025
|
| View |
IVDR-00856
|
Clungene HCG Pregnancy Rapid Test Cassette
|
hangzhou Clongene Biotech Co., Ltd. No. 1 Yichuang Road, Yuhang Sub-district, Yuhang District, hangzhou City, Zhejiang, China
|
China
|
05 June 2024
|
05 June 2025
|
| View |
IVDR-00858
|
Bioline Leptospira Multi-Device
|
Abbott Diagnostics Korea Inc. 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, 19077 Republic of Korea
|
Korea
|
05 June 2024
|
05 June 2025
|
| View |
IVDR-00859
|
Bioline Leptospira Device
|
Abbott Diagnostics Korea Inc. 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, 19077 Republic of Korea
|
Korea
|
05 June 2024
|
05 June 2025
|
| View |
IVDR-00860
|
bosphore Tropical Fever Panel Kit v1
|
Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme Sanayi ve Ticaret Anonim Sirketi Hasanpaca Mahallesi Beydagi Sok., No:1-9H Sultanbeyli, Istanbul, Turkiye
|
Turkiye
|
10 June 2024
|
10 June 2025
|
| View |
IVDR-00861
|
Rapiquick HIV 1/2 Rapid Test Cassette (WB/P/S)
|
Hangzhou AllTest Biotech Co., Ltd. 550#, Yihai Street, Hangzhou Economic and Technological Development Area 310018 Hangzhou, People's Republic of China
|
China
|
14 June 2024
|
14 June 2025
|