Identity
- Trade Name
- BN ProSpec® System FDA UDI
- Generic Name
- Nephelometry immunoassay analyser IVD FDA UDI
- Device Name
- The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF FDA UDI
- Model / Reference
- 10465217 FDA UDI
- Description
- The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF FDA UDI
Identifiers
- Catalog Number
- OVLI012 FDA UDI
- Primary DI / UDI-DI
- 00630414002736 FDA UDI
- 510(k) Number
- K001647 FDA UDI
- FDA Product Code
- JZW FDA UDI
- GMDN Term
- Nephelometry immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.4540 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nephelometry immunoassay analyser IVD
BN ProSpec® System by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephelometry immunoassay analyser IVD.
- BN II System — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Evaporation Caps for Control Vials (2.5 mL) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- N Cuvette Segments for BN II — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Evaporation Caps for Reagent Vials (5 ml) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K001647 also covers:
- BN II Additive — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Cleaner SCS — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Cuvette Segments for BN ProSpec® — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Evaporation Caps for Control Vials (2.5 mL) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Evaporation Caps for Reagent Vials (5 ml) — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 99f24eb0-73d1-49ef-a30c-012b83806ed8 36 fields · synced May 31, 2026