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 |
|---|---|---|
| Guangzhou Decheng Biotechnology Co., Ltd | 19 | 37% |
| Safecare Biotech (Hangzhou) Co., Ltd. | 5 | 10% |
| Hangzhou Laihe Biotech Co.,Ltd. | 5 | 10% |
| Pregmate Llc | 5 | 10% |
| Sugentech Inc._Osong Branch | 5 | 10% |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 4 | 8% |
| Coretests, Inc. | 3 | 6% |
| Wondfo Usa Co., Ltd. | 2 | 4% |
| The Bird And Be Co Inc | 1 | 2% |
| Mfb Fertility, Inc. | 1 | 2% |
| Naturalcycles Nordic Ab | 1 | 2% |
Company = labeler of record on GUDID. 11 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 | 50 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 |
Use these as the dimensions to specify in a tender line.
51 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, self-testing", from 11 companies. The largest labeler is Guangzhou Decheng Biotechnology Co., Ltd with 37% of records.
NGE (Test, Luteinizing Hormone (Lh), Over The Counter), LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
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.