A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinic
| Company | Devices | Share |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 38 | 37% |
| Primus Corporation | 26 | 25% |
| Diazyme Laboratories, Inc. | 7 | 7% |
| Arkray Usa, Inc. | 5 | 5% |
| Horiba Instruments Incorporated | 5 | 5% |
| Abbott Diagnostics Technologies As | 3 | 3% |
| Randox Laboratories Limited | 3 | 3% |
| Alfa Wassermann, Inc. | 2 | 2% |
| Carolina Liquid Chemistries Corporation | 2 | 2% |
| Kamiya Biomedical Company, Llc | 2 | 2% |
| Beckman Coulter, Inc. | 2 | 2% |
| Teco Diagnostics | 2 | 2% |
Company = labeler of record on GUDID. 18 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 |
|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 47 |
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | 41 |
| PDJ | Hemoglobin A1c test system | 8 |
| PDJ | Hemoglobin A1c Test System | 7 |
| JPD | HEMOGLOBIN A2 QUANTITATION | 3 |
| JFY | Enzymatic Method, Creatinine | 1 |
Use these as the dimensions to specify in a tender line.
103 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glycated haemoglobin (HbA1c) IVD, reagent", from 18 companies. The largest labeler is Bio-Rad Laboratories, Inc. with 37% of records.
LCP (Assay, Glycosylated Hemoglobin), LCP (ASSAY, GLYCOSYLATED HEMOGLOBIN), PDJ (Hemoglobin A1c test system), PDJ (Hemoglobin A1c Test System)
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.