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Lipoprotein, Low-Density, Antigen, Antiserum, Control
FDA product code DFC · Class 2 · Immunology
47
Registered devices
37
Adverse events
6
Recalls
43
510(k) clearances
Devices with this code
Tinaquant Apolipoprotein B ver2 — Roche Diagnostics GmbHPointe Lp(a) Reagent — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit — CAROLINA LIQUID CHEMISTRIES CORPORATIONK-ASSAY® Lp(a) Reagent — KAMIYA BIOMEDICAL COMPANY, LLCCAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D — CAROLINA LIQUID CHEMISTRIES CORPORATIONTinaquant Apolipoprotein B ver2 — Roche Diagnostics GmbHLipoprotein (a) Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDN Latex Lp(a) Reagent — Siemens Healthcare Diagnostics Products GmbHAlinity — ABBOTT IRELANDTina-quant Lipoprotein (a) Gen.2 Molarity — Roche Diagnostics GmbHLp (a) — RANDOX LABORATORIES LIMITEDTrinity Biotech — CLARK LABORATORIES, INC.Tina-quant Apolipoprotein B ver.2 — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific, Inc. Lipoprotein (a) — HORIBA INSTRUMENTS INCORPORATEDAlinity — ABBOTT LABORATORIESAtellica CH Lp(a) — Siemens Healthcare Diagnostics Inc.TorqMax™ — Spectranetics CorporationMedTest DX Lipoprotein (a) Calibrator for the BS480 — Medtest Dx, Inc.ARCHITECT — Abbott GmbHK-ASSAY® Lp(a) Control — KAMIYA BIOMEDICAL COMPANY, LLCAxis® Homocysteine EIA — AXIS-SHIELD DIAGNOSTICS LIMITEDK-ASSAY® Lp(a) Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCPointe Lp(a) Reagent — HORIBA INSTRUMENTS INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-20 | Randox Laboratories, Limited | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| 2024-12-20 | Randox Laboratories, Limited | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the variou |
| 2012-01-30 | Wako Chemicals USA, Inc. | In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease. |
| 2005-01-10 | Diasorin Inc. | QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitut |
| 2004-03-29 | Kamiya Biomedical Company | Assay result not consistent with the assigned control value |
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