10,000 results · 48ms · Sources: EU EUDAMED, US FDA

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

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification
FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

0425-MED-004425-00

Certificate
MDD Annex V·USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l.·ICIM S.P.A.·2 Basic UDI-DIs

Healgen (Private Label) - 194

FDA UDI
CONFIRM BIOSCIENCES, INC.·00895330002608·Healgen (DrugConfirm) - 9 Panel Dip Card - AMP1...

Healgen (Private Label) - 3104

FDA UDI
CONFIRM BIOSCIENCES, INC.·00895330002776·Healgen (DrugConfirm) - 10 Panel Dip Card - CLI...

Somatic Gene Mutation Detection System

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

MERIFLUOR(TM)-GIARDIA

FDA 510(k)
FDA Class 2 ·Microbiology

HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER

FDA 510(k)
FDA Class 2 ·Microbiology

T-Cup®

FDA UDI
Instant Technologies, Inc.·00817405021086·T-Cup® Multi-Drug Urine Test Cup with Adulteran...

Discover Panel over the counter

FDA registration
AMERICAN SCREENING CORPORATION·11 products·🇺🇸 United States

Healgen Accurate Home Multi-Drug Urine Test Cup

FDA registration
ZHEJIANG ORIENT GENE BIOTECH·11 products·🇨🇳 China

rapid diagnostic test

FDA registration
ASSURE TECH. (HANGZHOU) CO., LTD.·11 products·🇨🇳 China