Anti-Drug Antibody Biomarker Specimen Collection Kit 5000833

GUDID 00850025688888

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

Takeda Pharmaceuticals U.S.A., Inc.

Blood collection set, invasive

• Primary Device ID: 00850025688888
• NIH Device Record Key: 5b1a2e84-3b7e-480e-b89f-2be009cc3bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Drug Antibody Biomarker Specimen Collection Kit
• Version Model Number: 5000833
• Catalog Number: 5000833
• Company DUNS: 041877817
• Company Name: Takeda Pharmaceuticals U.S.A., 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025688888 [Primary]
GS1	05060147022339 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-07
• Device Publish Date: 2023-10-30

Devices Manufactured by Takeda Pharmaceuticals U.S.A., Inc.

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• 00850025688864 - BAXJECT II: 2024-03-08 Needleless Transfer Device
• 00850025688888 - Anti-Drug Antibody Biomarker Specimen Collection Kit: 2023-11-07The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectingspecimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher disease
• 00850025688888 - Anti-Drug Antibody Biomarker Specimen Collection Kit: 2023-11-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectings