Identity
- Trade Name
- N Latex Lp(a) Reagent FDA UDI
- Generic Name
- Lipoprotein A IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems FDA UDI
- Model / Reference
- 10446069 FDA UDI
- Description
- Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OQHL11 FDA UDI
- Primary DI / UDI-DI
- 00842768007552 FDA UDI
- 510(k) Number
- K013128 FDA UDI
- FDA Product Code
- DFC FDA UDI
- GMDN Term
- Lipoprotein A IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5600 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, kit, nephelometry/turbidimetry
N Latex Lp(a) Reagent 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, kit, nephelometry/turbidimetry.
- Diazyme — Diazyme Laboratories, Inc.
- Tinaquant Lipoprotein a Gen.2 — Roche Diagnostics Corp. · Class II
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- CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit — Carolina Liquid Chemistries Corp. · Class II
- Atellica CH Lp(a) — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Lp (a) — Randox Laboratories, Ltd. · Class II
- LIPOPROTEIN (a) (Lp (a)) — Randox Laboratories, Ltd. · Class I
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 50a4195e-9c35-4706-97cf-0af6e8fce221 37 fields · synced May 30, 2026