Home › Device types › JHI
Visual, Pregnancy Hcg, Prescription Use
FDA product code JHI · Class 2 · Clinical Chemistry
231
Registered devices
3,831
Adverse events
43
Recalls
375
510(k) clearances
Devices with this code
OSOM hCG Urine Ctrl Set — SEKISUI DIAGNOSTICS, LLCHenry Schein — HENRY SCHEIN, INC.AIMSTRIP PREGNANCY — GERMAINE LABORATORIES, INCPreview — WONDFO USA CO., LTD.Atellica™ IM ThCG DIL — Siemens Healthcare Diagnostics Inc.Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells — MONOBIND, INC.Proov — Mfb Fertility, Inc.Tanner Scientific® — MERCEDES MEDICAL, LLCAC&C DeTec hCG Pregnancy Test Device — Immunostics Company, IncADVIA Centaur® Total hCG (ThCG) — Siemens Healthcare Diagnostics Inc.Prabadin — Prabadin CorpNA — W.H.P.M. INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Sofia — QUIDEL CORPORATIONChoiceMMed — Beijing Choice Electronic Technology Co., Ltd.HCG dipstick Test — DRG International IncAlereTM — Alere San Diego, Inc.Wondfo — WONDFO USA CO., LTD.Teco Diagnostics One-Step Pregnancy Dipstick Test — TECO DIAGNOSTICSIcon — Beckman Coulter, Inc.Wondfo — WONDFO USA CO., LTD.CLINITEK Status® Connector — Siemens Healthcare Diagnostics Inc.Detector hCG Stick — Immunostics Company, IncN/A — W.H.P.M. INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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 |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
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