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In vitro diagnostic medical devices
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Reagents
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Immunochemistry (immunology)
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Fertility / pregnancy hormones / proteins
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Pregnancy testing hormones / proteins
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Pregnancy testing hormones - other
Pregnancy testing hormones - other
W0102050299
50 devices
Devices
DELFIA/AutoDELFIA PAPP-A/Free hCGβ Dual DBS kit
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Al-1008 Plgf Elisa
Ansh Labs
·
,
US
IVD Annex II List B
CE/IVDD
DELFIA/AutoDELFIA PlGF 1-2-3
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Atlas HCG Latex Reagent, 4 ml/Vial, Individually Packed, 1 Vial /Box.
Atlas Medical GmbH
·
,
DE
IVD General
CE/IVDD
DELFIA Xpress PlGF
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
DELFIA Xpress PAPP-A
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Al-109
Ansh Labs
·
,
US
IVD General
CE/IVDD
DELFIA Xpress PAPP-A
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Toda Preterm Diag 20
Toda Pharma
·
,
FR
IVD General
CE/IVDD
Toda Preterm Diag 10
Toda Pharma
·
,
FR
IVD General
CE/IVDD
AutoDELFIA hAFP/Free hCGß Dual
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Atlas HCG Latex Reagent, 2 ml/Vial, Individually Packed, 1 Vial /Box.
Atlas Medical GmbH
·
,
DE
IVD General
CE/IVDD
AFP screening IRMA KIT
IMMUNOTECH s.r.o.
·
,
CZ
Class C
CE/IVDR
Fetal Fibronectin Rapid Test Kit (Colloidal gold method)
Nanjing Synthgene Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Atlas HCG Latex, 50 Tests
Atlas Medical GmbH
·
,
DE
IVD General
CE/IVDD
IDS-iSYS Free Testosterone
Immunodiagnostic Systems Limited
·
,
GB
IVD General
CE/IVDR
FDA 510(k)
K240865
Active
Cleared 23 Oct 2024
+1
authorizations
DELFIA Xpress PlGF
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Atlas HCG Latex Kit, 100 Tests (4 ml Latex +3 more)
Atlas Medical GmbH
·
,
DE
IVD General
CE/IVDD
iGFBP-1 Rapid Test
Zhejiang Anji Saianfu Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
DELFIA Xpress PAPP-A
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
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