A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.
| Company | Devices | Share |
|---|---|---|
| Horiba Instruments Incorporated | 8 | 16% |
| Sekisui Diagnostics, Llc | 7 | 14% |
| Denka Company Limited | 6 | 12% |
| Randox Laboratories Limited | 4 | 8% |
| Vitalscientific | 4 | 8% |
| Siemens Healthcare Diagnostics Inc. | 4 | 8% |
| Carolina Liquid Chemistries Corporation | 4 | 8% |
| Roche Diagnostics Gmbh | 3 | 6% |
| Horiba Abx Sas | 2 | 4% |
| Stanbio Laboratory, L.P. | 2 | 4% |
| Beckman Coulter, Inc. | 2 | 4% |
| Drew Scientific, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | 17 |
| MRR | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN | 16 |
| LBR | LDL & VLDL PRECIPITATION, HDL | 10 |
| PYP | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test | 6 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry", from 15 companies. The largest labeler is Horiba Instruments Incorporated with 16% of records.
MRR (System, Test, Low Density, Lipoprotein), MRR (SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN), LBR (LDL & VLDL PRECIPITATION, HDL), PYP (Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.