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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry - rapid tests & point of care
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Fertility / pregnancy rt & poc
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Hcg - rt & poc
Hcg - rt & poc
W0102160302
523 devices
HCG Pregnancy Rapid Test
Healgen Scientific Limited Liability Company
·
,
United States
IVD for self-testing
CE/IVDD
PreventID® hCG
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
Test De Grossesse Hcg Numérique (Urine)
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Innovita
Gaobeidian PRISES Biotechnology Co., Ltd
·
,
China
IVD for self-testing
CE/IVDD
Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)
Jiangsu Konsung Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HCG Pregnancy Rapid Test
Healgen Scientific Limited Liability Company
·
,
United States
IVD for self-testing
CE/IVDD
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HCG Pregnancy Rapid Test Cassette (Serum, Plasma and Urine)
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
OneStep Pregnancy Test
Tianjin New Bay Bioresearch Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
hCG Pregnancy Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
hCG One Step Pregnancy Test
Sejoy Biomedical Co., Ltd.
·
,
China
IVD for self-testing
FDA 510(k)
K212447
Active
Cleared 18 Feb 2022
CE/IVDD
hCG Pregnancy Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD for self-testing
CE/IVDD
HCG Pregnancy Rapid Test
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Romed
Hubei MEIBAO Biotechnology Co., Ltd
·
,
China
Class B
CE/IVDD
CE/IVDR
One Step HCG Pregnancy Test (Colloidal Gold)
Nantong Diagnos Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Pregnancy Test for Self Testing
Nantong EgensBiotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
TruVue
BioFynder Limited
·
,
United Kingdom
IVD General
CE/IVDD
Test ciążowy (hCG) kasetki 40 szt.
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
One Step HCG Pregnancy Test
Wuhan J.H. Bio-Tech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Accu-Tell® HCG Multi-Line Strip (Urine)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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