Identity
- Trade Name
- N LP(a) Standard SY FDA UDI
- Generic Name
- Lipoprotein A IVD, calibrator FDA UDI
- Device Name
- Calibration of Lp(a) assay on BN Systems FDA UDI
- Model / Reference
- 10873686 FDA UDI
- Description
- Calibration of Lp(a) assay on BN Systems FDA UDI
Identifiers
- Catalog Number
- OQCV07 FDA UDI
- Primary DI / UDI-DI
- 00630414285009 FDA UDI
- 510(k) Number
- K013126 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Lipoprotein A IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
N LP(a) Standard SY by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lipoprotein A IVD, calibrator.
- ADVIA® Chemistry LP(A) CALIBRATOR — Siemens Healthcare Diagnostics · Class II
- Pointe Scientific, Inc. Lipoprotein (a) — POINTE SCIENTIFIC, INC. · Class II
- Preciset Lp(a) Gen.2 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Preciset Lp(a) Gen.2 — Roche Diagnostics Corp. · Class II
- Lp(a) Cal Set — Sentinel Ch. Srl · Class II
- Atellica CH Lp(a) Calibrator — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K013126 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 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 401ecc3f-fcc9-4ec2-932a-2e4f8a36ef17 37 fields · synced Jun 6, 2026