Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Haptoglobin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Haptoglobin 228 Tests FDA UDI
- Model / Reference
- 09D9124 FDA UDI
- Description
- Haptoglobin 228 Tests FDA UDI
Identifiers
- Catalog Number
- 09D9124 FDA UDI
- Primary DI / UDI-DI
- 00380740169886 FDA UDI
- FDA Product Code
- DAD FDA UDI
- GMDN Term
- Haptoglobin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Category: Haptoglobin IVD, kit, nephelometry/turbidimetry
Architect by Abbott Ireland — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haptoglobin IVD, kit, nephelometry/turbidimetry.
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- Tinaquant Haptoglobin ver2 — Roche Diagnostics Corp. · Class II
- Haptoglobin Kit (Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- N Antiserum to Human Haptoglobin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ADVIA® Chemistry HAPT Haptoglobin Reagents — Siemens Healthcare Diagnostics · Class II
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
- Abbott Ireland
Sources (1)
- FDA UDI 0c8f08c0-0398-448e-98b9-a09a38cd8dfd 36 fields · synced Jun 8, 2026