Home › Device types › JHI
Visual, Pregnancy Hcg, Prescription Use
FDA product code JHI · Class 2 · Clinical Chemistry
0
Registered devices
3,947
Adverse events
47
Recalls
376
510(k) clearances
Devices with this code
Detector hCG — Immunostics Company, IncPreview — WONDFO USA CO., LTD.FastPack® IP hCG Diluent Kit (25) — QUALIGEN INC.AlereTM — Alere San Diego, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCFirst Sign® — HEMOSURE INC.QuickVue — QUIDEL CORPORATIONBioSign® RC hCG S/U card — PRINCETON BIOMEDITECH CORPORATIONhCG Pregnancy Serum/Urine Combo Test Strip(10/20) — ASSURE TECH. (HANGZHOU) CO., LTD.Moore Medical — MOORE MEDICAL LLCDetector hCG Stick — Immunostics Company, IncPro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC.Wondfo — WONDFO USA CO., LTD.LSL HEALTHCARE — LSL Industries, LLCSofia — QUIDEL CORPORATIONINSTANT-VIEW Pregnancy Urine Dip-Strip Test — ALFA SCIENTIFIC DESIGNS, INC.Fluoro-CheckTM beta-hCG — NANO-DITECH CORPORATIONTeco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test — TECO DIAGNOSTICSHenry Schein — HENRY SCHEIN, INC.Pregnancy Combo Cassette Test — ALFA SCIENTIFIC DESIGNS, INC.AdexusDx hCG Test — NOWDIAGNOSTICS, INC.Wondfo — WONDFO USA CO., LTD.To Life HCG Pregnancy Test Strip — Immunostics Company, IncIcon — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2024-08-23 | Princeton Biomeditech Corp | This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product l |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.