10,000 results · 46ms · Sources: EU EUDAMED, US FDA

HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

HBsAg Rapid Test Cassette

Device
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

HBsAg Rapid Test Cassette

Device
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

HBsAg Rapid Test Cassette

Device
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

HBsAg Rapid Test Cassette

Device
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

HIV MULTIPLE (1/2) REAGENTS - OTHER

Device
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

COVID-19 & Influenza A/B Antigen Nasal Test Kit

Device
EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country

CORONAVIRUS [obsolete from 2025-01-01]

Device
EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market

CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·On the market

CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·On the market

CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·On the market

SARS-Cov-2&Influenza A/B Combo Rapid Test Cassette (swab)

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Zhongshan Bio-Tech Co., Ltd.·On the market

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Zhongshan Bio-Tech Co., Ltd.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device
EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market

Novel Coronavirus(SARS-Cov-2)Antigen Rapid Test Device(saliva)

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

SARS-CoV-2 Antigen Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen FGFR RGQ RT-PCR Kit

Test, Follicle Stimulating Hormone (Fsh), Over The Counter

FDA classification
FDA Class 1 ·Test, Follicle Stimulating Hormone (Fsh), Over The Counter