Identity
- Trade Name
- Lp (a) FDA UDI
- Generic Name
- Lipoprotein A IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. FDA UDI
- Model / Reference
- LP2757 FDA UDI
- Description
- Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- LP2757 FDA UDI
- Primary DI / UDI-DI
- 05055273209198 FDA UDI
- 510(k) Number
- K011568 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Lp (a) by Randox Laboratories, 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.
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- Atellica CH Lp(a) — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ADVIA® Chemistry LP(A) Lipoprotein(a) Reagents — Siemens Healthcare Diagnostics · Class II
- Tina-quant Lipoprotein (a) Gen.2 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K011568 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 |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 156bdb7b-4adc-4d3a-8e23-5a09dd3ecb34 37 fields · synced May 30, 2026