32 results
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8ms
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Sources: EU EUDAMED, US FDA
ALBUMIN INCL. UALBUMIN RT & POC
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·On the market
H. PYLORI - RT & POC
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·On the market
SPECIFIC PROTEINS RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·On the market
PSA - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shanghai Chemtron Biotech Co., Ltd.·On the market
CHLAMYDIA AG - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shanghai Chemtron Biotech Co., Ltd.·On the market
FSH - RT & POC
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·On the market
LH - RT & POC
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·On the market
HCG - RT & POC
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ®® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ® COVID-19 Ag Rapid Test (Colloidal Gold)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ® COVID-19 (SARS-CoV-2)Antigen Rapid Test Kit(Saliva)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ®® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
Chemtrue ®COVID-19 (SARS-CoV-2)Antigen Rapid Test Kit(Nasal Swab)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Chemtron Biotech Co., Ltd.·On the market
V1 076482 0004
Certificate
IVDD Annex IV (excluding sections 4, 6)·Shanghai Chemtron Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·7 Basic UDI-DIs
No.V1 076482 0004
Certificate
IVDD Annex IV (excluding sections 4, 6)·Shanghai Chemtron Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
One-Step Microalbuminuria(MAU) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
H.pylori Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
Fecal Occult Blood Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device