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Anti-Drug Antibody Biomarker Specimen Collection Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Anti-Drug Antibody Biomarker Specimen Collection Kit 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 collectingspecimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher disease FDA UDI
- Model / Reference
- 5000833 FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 5000833 FDA UDI
- Primary DI / UDI-DI
- 00850025688888 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
- 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood collection set, invasive
Anti-Drug Antibody Biomarker Specimen Collection Kit by Takeda Pharmaceuticals U.S.A., Inc. — Class II — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
Sources (1)
- FDA UDI 5b1a2e84-3b7e-480e-b89f-2be009cc3bf4 34 fields · synced Jun 8, 2026