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Haptoglobin Kit (Immunoturbidimetric Method)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Haptoglobin Kit (Immunoturbidimetric Method) FDA UDI
- Generic Name
- Haptoglobin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- None FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970291985161 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Haptoglobin IVD, kit, nephelometry/turbidimetry
Haptoglobin Kit (Immunoturbidimetric Method) by Medicalsystem Biotechnology Co., Ltd. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Haptoglobin IVD, kit, nephelometry/turbidimetry.
- Optilite Haptoglobin Kit — The Binding Site Group · Class II
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- Tinaquant Haptoglobin ver2 — Roche Diagnostics Corp. · 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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medicalsystem Biotechnology Co., Ltd.
Sources (2)
- FDA UDI de6d0402-f30c-4265-bfad-8145bbadac00 32 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 4, 2026