Identity
- Trade Name
- N Lp(a) Control SY FDA UDI
- Generic Name
- Lipoprotein A IVD, control FDA UDI
- Device Name
- Assayed control for Lp(a) assay on BN Systems FDA UDI
- Model / Reference
- 10873687 FDA UDI
- Description
- Assayed control for Lp(a) assay on BN Systems FDA UDI
Identifiers
- Catalog Number
- OQCW07 FDA UDI
- Primary DI / UDI-DI
- 00630414285016 FDA UDI
- 510(k) Number
- K013130 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Lipoprotein A IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Lipoprotein A IVD, control
N Lp(a) Control SY by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lipoprotein A IVD, control.
- Diazyme — Diazyme Laboratories, Inc.
- Lp(a) Control Set — Sentinel Ch. Srl · Class I
- Pointe Lipoprotein (a) Control Set — POINTE SCIENTIFIC, INC. · Class I
- Diazyme — Diazyme Laboratories, Inc.
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- N Lp(a) Control SY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K013130 also covers:
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 57cc999e-e4a6-4085-9767-34d68b592792 37 fields · synced May 30, 2026