Identity
- Trade Name
- N Antiserum to Human Haptoglobin FDA UDI
- Generic Name
- Haptoglobin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of haptoglobin in human serum and plasma on BN Systems FDA UDI
- Model / Reference
- 10446304 FDA UDI
- Description
- Quantitative determination of haptoglobin in human serum and plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OSAV09 FDA UDI
- Primary DI / UDI-DI
- 00842768009853 FDA UDI
- 510(k) Number
- K860894 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Haptoglobin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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
No
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
N Antiserum to Human Haptoglobin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haptoglobin IVD, kit, nephelometry/turbidimetry.
- Optilite Haptoglobin Kit — The Binding Site Group · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- Tinaquant Haptoglobin ver2 — Roche Diagnostics Corp. · Class II
- Haptoglobin Kit (Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ADVIA® Chemistry HAPT Haptoglobin Reagents — Siemens Healthcare Diagnostics · Class II
- Tinaquant Haptoglobin — Roche Diagnostics Corp. · Class II
- Atellica CH HAPT2 — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K860894 also covers:
- N Antiserum to Human Antithrombin III — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein A-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein A-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein B — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein B — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Fibrinogen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Haptoglobin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Plasminogen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human a1-acid Glycoprotein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human a1-acid Glycoprotein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI fb822dc2-1681-40d1-baff-0623e6569cf2 37 fields · synced May 30, 2026