A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a liquid chromatography method.
| Company | Devices | Share |
|---|---|---|
| Wuxi Biohermes Bio & Medical Technology Co.,Ltd. | 21 | 40% |
| Bio-Rad Laboratories, Inc. | 13 | 25% |
| Tosoh Corporation | 9 | 17% |
| Primus Corporation | 4 | 8% |
| Sebia | 3 | 6% |
| Canterbury Scientific Limited | 2 | 4% |
| Siemens Healthcare Diagnostics Inc. | 1 | 2% |
Company = labeler of record on GUDID. 7 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 | 20 |
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | 13 |
| PDJ | Hemoglobin A1c Test System | 7 |
| JKA | Tubes, vials, systems, serum separators, blood collection | 6 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 |
| PDJ | Hemoglobin A1c test system | 2 |
Use these as the dimensions to specify in a tender line.
53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography", from 7 companies. The largest labeler is Wuxi Biohermes Bio & Medical Technology Co.,Ltd. with 40% of records.
LCP (Assay, Glycosylated Hemoglobin), LCP (ASSAY, GLYCOSYLATED HEMOGLOBIN), PDJ (Hemoglobin A1c Test System), JKA (Tubes, vials, systems, serum separators, blood collection)
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.