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

FDA UDI

Class II (US FDA UDI)

by Shire Human Genetic Therapies, Inc.

Identity

Trade Name
Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient FDA UDI
Generic Name
Blood collection set, invasive FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
05060147022339 FDA UDI
FDA Product Code
PQD FDA UDI
GMDN Term
Blood collection set, invasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1675 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient by Shire Human Genetic Therapies, Inc. — Class II — FDA UDI — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shire Human Genetic Therapies, Inc.

Sources (1)

  • FDA UDI 649f0530-db08-44a9-802d-b45591046075 34 fields · synced Jun 20, 2026