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

GUDID 05060147022339

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.

SHIRE HUMAN GENETIC THERAPIES, INC.

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• Primary Device ID: 05060147022339
• NIH Device Record Key: 649f0530-db08-44a9-802d-b45591046075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient
• Version Model Number: 1
• Company DUNS: 626119668
• Company Name: SHIRE HUMAN GENETIC THERAPIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060147022339 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-07
• Device Publish Date: 2019-08-28

Devices Manufactured by SHIRE HUMAN GENETIC THERAPIES, INC.

• 00642621074000 - BAXJECT II Hi-Flow: 2023-10-12 Needleless Transfer Device
• 05060147022339 - Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient: 2021-04-07The 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.
• 05060147022339 - Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient: 2021-04-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting