A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, u
| Company | Devices | Share |
|---|---|---|
| Weihai Kangzhou Biotechnology Engineering Co., Ltd | 10 | 13% |
| Wondfo Usa Co., Ltd. | 9 | 11% |
| Amplim, Llc | 9 | 11% |
| Nantong Egens Biology Technic Co., Ltd. | 8 | 10% |
| Equinox Biotech Co., Ltd. | 6 | 8% |
| Germaine Laboratories, Inc | 4 | 5% |
| Hangzhou Alltest Biotech Co., Ltd. | 3 | 4% |
| Healgen Scientific Limited Liability Company | 3 | 4% |
| Church & Dwight Co., Inc. | 3 | 4% |
| Alfa Scientific Designs, Inc. | 3 | 4% |
| Anhui Deepblue Medical Technology Co.,Ltd | 2 | 3% |
| Hangzhou Clongene Biotech Co., Ltd. | 2 | 3% |
Company = labeler of record on GUDID. 27 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 |
|---|---|---|
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 67 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 17 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 13 |
| CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 3 |
| NGE | Test, luteinizing hormone (lh), over the counter | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
Use these as the dimensions to specify in a tender line.
79 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical", from 27 companies. The largest labeler is Weihai Kangzhou Biotechnology Engineering Co., Ltd with 13% of records.
NGE (Test, Luteinizing Hormone (Lh), Over The Counter), CEP (Radioimmunoassay, Luteinizing Hormone), LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), CEP (RADIOIMMUNOASSAY, LUTEINIZING HORMONE)
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.