A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analy
| Company | Devices | Share |
|---|---|---|
| Sysmex Corporation | 22 | 34% |
| Horiba Abx Sas | 14 | 22% |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 9 | 14% |
| Abbott Laboratories | 7 | 11% |
| Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag | 3 | 5% |
| Siemens Healthcare Diagnostics Inc. | 2 | 3% |
| Incell Corporation, Llc | 2 | 3% |
| Stemcell Technologies Canada Inc | 1 | 2% |
| Agilent Technologies Singapore Pte Ltd | 1 | 2% |
| Bühlmann Laboratories Ag | 1 | 2% |
| Grifols Diagnostic Solutions Inc. | 1 | 2% |
| Becton, Dickinson And Company | 1 | 2% |
Company = labeler of record on GUDID. 12 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 |
|---|---|---|
| GGK | Products, Red-Cell Lysing Products | 53 |
| GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 17 |
| GKZ | Counter, differential cell | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| LIO | Device, Specimen Collection | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood cell lysis reagent IVD", from 12 companies. The largest labeler is Sysmex Corporation with 34% of records.
GGK (Products, Red-Cell Lysing Products), GGK (PRODUCTS, RED-CELL LYSING PRODUCTS), GKZ (Counter, differential cell), 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.