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In vitro diagnostic medical devices
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Clinical chemistry
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Substrates
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Phenylketonuria
Phenylketonuria
W01010236
7 devices
Devices
Neonatal Phenylalanine
Labsystems Diagnostics Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Neonatal Phenylalanine
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
GUDID
on market
GSP Neonatal Phenylalanine kit
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Neonatal Phenylalanine
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
GUDID
on market
GSP Neonatal Phenylalanine kit
Wallac Oy
·
,
FI
IVD Annex II List B
CE/IVDD
Phenylalanine (PKU) neonatal Screening Assay
Ibl International GmbH
·
,
DE
IVD Annex II List B
CE/IVDD
Phenylalanine (Phe) Diagnostic Kit (Fluorometric Assay)
Darui Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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