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In vitro diagnostic medical devices
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Immunochemistry - rapid tests & point of care
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Fertility / pregnancy rt & poc
Fertility / pregnancy rt & poc
W01021603
966 devices
Subcategories
5
W0102160301
Fsh - rt & poc
65
devices
W0102160302
Hcg - rt & poc
523
devices
W0102160303
Hpl - rt & poc
1
device
W0102160304
Lh - rt & poc
263
devices
W0102160399
Fertility/pregnancy rt & poc - other
114
devices
Devices
One-Step HCG Pregnancy Test
Shanghai Chemtron Biotech Co., Ltd.
·
,
China
IVD for self-testing
FDA 510(k)
×2
K132085
Active
Cleared 12 Nov 2013
CE/IVDD
hCG Pregnancy Enhanced Sensitivity Rapid Test Cassette
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
hCG Pregnancy Rapid Test Dipstick (Urine)
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
RapidFor™ hCG + LH Combo Rapid Test Kit
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
Fertilitätsmonitor Advanced
Spd Swiss Precision Diagnostics GmbH
·
,
Switzerland
IVD for self-testing
CE/IVDD
FSH/LH/PRL Rapid Quantitative Test (Fluorescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
600601
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
One Step HCG Pregnancy Test (Colloidal Gold)
Wuhan J.H. Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Ovulation Test (Colloidal Gold)
Wuhan J.H. Bio-Tech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
One Step Ovulation Test Strip (Urine)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
GUDID
on market
LH Quantitative Test Kit (Time-Resolved FIA)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
LH One Step Ovulation Test
Sejoy Biomedical Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Luteinizing Hormone (LH) Fluorescence ImmunoAssay (FIA) Test
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
LH Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
LH Ovulation Rapid Test
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Heltes
Artron Laboratories Inc.
·
,
Canada
IVD for self-testing
CE/IVDD
Ovu Test
Core Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
One Step Ovulation Urine Test
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
LH Ovulation Rapid Test
Healgen Scientific Limited Liability Company
·
,
United States
IVD for self-testing
CE/IVDD
Luteinizing hormone (LH) Quantitative Test Kit(Dry Fluorescence Immunochromatog…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
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