572 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: China
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JIANGXI AOV MATERNITY & BABY PRODUCTS CO., LTD.
FDA registration
JIANGXI AOV MATERNITY & BABY PRODUCTS CO., LTD.·1 product·🇨🇳 China
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO
FDA Enforcement
Class II
·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
FDA Enforcement
Class I
·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021
One Step Morphine (MOP) Test Device(Hair) (Immunofluorescence )
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
FDA Enforcement
Class II
·Ongoing·Acon Biotech (Hangzhou) Co., Ltd.·April 27, 2022
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
FDA Enforcement
Class I
·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
EasyNAT SARS-CoV-2/SARS-CoV-2 Delta Variant Assay
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Ustar Biotechnologies (Hangzhou) Ltd.·1 device
SARS-CoV-2 Test Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Xiamen Zeesan Biotech Co., Ltd.·1 device
SARS-CoV-2 Antigen Test
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Antigen (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device