SHIRE HUMAN GENETIC THERAPIES, INC.

Address:1445 Lawrence Drive,Thousand Oaks,CA,91320,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (1)

Premarket Exempt

Yes

Clear

Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient - 05060147022339 Catalog Number :

Device Description : The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is t The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting specimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher.

Device Class : 2

Duns Number: 626119668

Premarket Exempt : Yes

Product Code : PQD

Prescription Use : Yes

Device Count : 1

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