1434-MDD-107/2021

Certificate

MDD Annex II Section 4·PRP Science Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·21 Basic UDI-DIs

ASPE CONSEIL

Authorized representative

🇫🇷 France·1 Manufacturer·4 Devices

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market·3 countries

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

HEPATITIS C VIRUS - NA REAGENTS

Device

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

HEPATITIS B VIRUS - NA REAGENTS

Device

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

AccuSign® DOA 5/MET card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000372·AccuSign® DOA 5 ME/O/C/TH/P card; 35 Test kit; CE

AccuSign® DOA 5/MET card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000389·AccuSign® DOA 5 ME/O/C/TH/P card; 10 Test kit; CE

PreKnow

FDA UDI

IDUN SOLUTIONS LLC·00857275007179·PreKnow 5-Panel Instant Multi-Drug Screen Test ...

SAFECUP III MULTIDRUG N5

FDA UDI

GERMAINE LABORATORIES, INC·00695684454852·

Status Stick™ 5/MET Stick

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816001386·Status Stick™ME/O/C/TH/P stick; 10 Test kit

PreKnow

FDA UDI

IDUN SOLUTIONS LLC·00857275007568·5 Multi Drug Test Panel ( AMP1000 • COC 300 •...

SAFECUP II MULTIDRUG N5

FDA UDI

GERMAINE LABORATORIES, INC·00695684454555·Lateral flow immunoassay for the detection of d...

AccuSign® DOA 5/AMP card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000365·AccuSign® DOA 5 A/O/C/TH/P card; 10 Test kit; CE

BluRapids™

FDA UDI

MERCEDES MEDICAL, LLC·00850011007020·BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/CO...

Status Stick™ 5/MET Stick

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816001379·Status Stick™ME/O/C/TH/P stick; 35 Test kit

AccuSign® DOA 5/AMP card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000358·AccuSign® DOA 5 A/O/C/TH/P card; 35 Test kit; CE

AIMSCREEN MULTIDRUG N5

FDA UDI

GERMAINE LABORATORIES, INC·00695684405250·Lateral flow immunoassay for the detection of d...

StatusFirst™ 5/MET card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000396·StatusFirst™ ME/O(2K)/C/TH/P card; 25 Test kit;...