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IVDR-00521
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Quick Profile™ MDMA Test Card
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Lumiquick Diagnostics, Inc. 2946 Scott Blvd. Sta Clara California, USA Mfd By: Xiamen Bosn Biotech Co., Ltd. 90-94 Tianfeng Road, Jimei Industrial Park, Xiamen, Pujihan, PRC
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China
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22 April 2024
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15 October 2026
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| View |
IVDR-00522
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RightSign® OPI Rapid Test Cassette (URINE)
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Hangzhou Biotest Biotech Co., Ltd. - 17# Futai Road, Zhongtai Street, Yuhang District, 311121 Hangzhou, People's Republic of China
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China
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01 September 2022
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15 October 2026
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| View |
IVDR-00523
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BASECHECK™ MULTIDRUG 2 DRUGS RAPID TEST CASSETTE (URINE) (MET500/THC50)
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Acro Biotech Inc. - California, United States of America mfd. By: Hangzhou Alltest Biotech Co., Ltd. - Hangzhou, PR China
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China
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15 October 2020
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15 October 2021
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| View |
IVDR-00524
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RHOFINAL ANTI-D (ANTI-RHO) (IgM + IgG) MONOCLONAL
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Tulip Diagnostics (P) Ltd. And Coral Clinical Systems (A Division of Tulip Diagnostics (P) Ltd.) - Goa, India mfd. By: Tulip Diagnostics (P) Ltd. - Goa, India
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India
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28 September 2021
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15 October 2026
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| View |
IVDR-00525
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VIROTROL® SYPHILIS LR-A UNASSAYED (HUMAN) SEROLOGY CONTROL
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Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad Laboratories Inc. - Irvine, CA, United States
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USA
|
07 October 2021
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19 October 2026
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| View |
IVDR-00526
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CLUE ONE STEP HCG URINE DEVICE
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Tulip Diagnostics (P) Ltd. - Goa, India mfd. By: Orchid Biomedical Systems - A Division of Tulip Diagnostics (P) Ltd. - Goa, India
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India
|
23 October 2020
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23 October 2021
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| View |
IVDR-00527
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MERISCREEN HIV 1-2 WB ONE STEP RAPID TEST FOR DETECTION OF ANTI-HIV IN HUMAN SERUM/PLASMA/WHOLE BLOOD
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Meril Diagnostics Private Limited - Gujarat, India
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India
|
24 November 2020
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24 November 2021
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| View |
IVDR-00528
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Quick Profile™ Cocaine Test Card
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LumiQuick Diagnostics, Inc. 2946 Scoot Blvd. Santa Clara California 95054 USA
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USA
|
08 June 2022
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20 October 2026
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| View |
IVDR-00529
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GRAVI CHECK ONE STEP HCG URINE/SERUM DEVICE
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Tulip Diagnostics (P) Ltd. - Goa, India mfd. By: Orchid Biomedical Systems - A Division of Tulip Diagnostics (P) Ltd. - Goa, India
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India
|
20 October 2020
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20 October 2021
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| View |
IVDR-00530
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ID-INTERNAL QUALITY CONTROL
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Bio-Rad Laboratories (Singapore) mfd. By: DiaMed Holding GmbH - FR, Switzerland
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Switzerland
|
06 November 2020
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06 November 2021
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| View |
IVDR-00531
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COOMBS-CONTROL IgG HUMAN RED CELL CONTROL FOR THE ANTIHUMAN GLOBULIN
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Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: DiaMed Holding GmbH - FR, Switzerland
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Switzerland
|
06 November 2020
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06 November 2021
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| View |
IVDR-00532
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RAPIQUICK LEPTOSPIRA RAPID TEST DEVICE
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Hangzhou AllTest Biotech Co., Ltd. - Hangzhou, People's Republic of China
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China
|
06 November 2020
|
06 November 2021
|
| View |
IVDR-00533
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HCG PREGNANCY TEST CASSETTE KIT
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Nantong Egens Biotechnology Co., Ltd. - Nantong, China
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China
|
06 November 2020
|
06 November 2021
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| View |
IVDR-00534
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DETERMINE HBsAg 2.0
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Abbott Diagnostics Medical Co., Ltd. - 357 Matshuhidai Matsudo-shi, Chiba 270-2214 Japan
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Japan
|
26 August 2022
|
06 November 2026
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| View |
IVDR-00535
|
Quick Profile™ Opiate Test Card
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Lumiquick Diagnostics, Inc. 2946 Scott Blvd. Sta. Clara California, USA Mfd. By: Xiamen Boson Biotech Co., Ltd. 90-94 Tianfeng Road, Jimei North Industrial Park, 361021 Xiamen, Fujihan, P.R.C.
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USA
|
27 January 2023
|
06 November 2026
|
| View |
IVDR-00536A
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VIROTROL® I ANTI-HIV 1 POSITIVE CONTROL; Size/Codes: 00100C - 1x5mL
|
Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad Laboratories Inc. - Irvine, CA, United States
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USA
|
07 October 2021
|
01 December 2026
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| View |
IVDR-00536B
|
VIROTROL® I ANTI-HIV 1 POSITIVE CONTROL; Size/Codes: 00100F - 1x5mL
|
Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad Laboratories Inc. - Irvine, CA, United States
|
USA
|
07 October 2021
|
01 December 2026
|
| View |
IVDR-00536C
|
VIROTROL® I ANTI-HIV 1 POSITIVE CONTROL; Size/Codes: 00101F - 10x4mL
|
Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad Laboratories Inc. - Irvine, CA, United States
|
USA
|
07 October 2021
|
01 December 2026
|
| View |
IVDR-00537
|
EGENS ONE STEP TEST DEVICE PREGNANCY (URINE/SERUM)
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Nantong Egens Biotechnology Co., Ltd. - Nantong, P.R. China
|
China
|
01 December 2020
|
01 December 2021
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| View |
IVDR-00538A
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VIROCLEAR® UNASSAYED (HUMAN) SEROLOGY CONTROL; Size/Code: 00106- 1x5mL
|
Bio-Rad Laboratories (Singapore) Pte. Ltd. - Singapore mfd. By: Bio-Rad Laboratories Inc. - Irvine, CA, United States
|
USA
|
07 October 2021
|
01 December 2026
|