A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and be
| Company | Devices | Share |
|---|---|---|
| Spd Swiss Precision Diagnostics Gmbh | 37 | 6% |
| Easy Healthcare Corporation | 34 | 5% |
| Wondfo Usa Co., Ltd. | 32 | 5% |
| Walgreen Co. | 31 | 5% |
| Guangzhou Decheng Biotechnology Co., Ltd | 30 | 5% |
| Immunostics Company, Inc | 22 | 3% |
| Princeton Biomeditech Corporation | 22 | 3% |
| Germaine Laboratories, Inc | 21 | 3% |
| Equinox Biotech Co., Ltd. | 20 | 3% |
| Amplim, Llc | 19 | 3% |
| Hangzhou Alltest Biotech Co., Ltd. | 18 | 3% |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd | 18 | 3% |
Company = labeler of record on GUDID. 91 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 |
|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 661 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 118 |
| JHI | Visual, pregnancy hCG, prescription use | 38 |
| LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 35 |
| DHA | System, Test, Human Chorionic Gonadotropin | 22 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 18 |
Use these as the dimensions to specify in a tender line.
632 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical", from 91 companies. The largest labeler is Spd Swiss Precision Diagnostics Gmbh with 6% of records.
LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), JHI (Visual, Pregnancy Hcg, Prescription Use), JHI (Visual, pregnancy hCG, prescription use), 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.