Product code JHI
- Device name
- Visual, Pregnancy Hcg, Prescription Use
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1155
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) | True Diagnostics, Inc. | 2017-12-22 |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | Assure Tech. Co., Ltd. | 2016-02-24 |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | 2014-04-08 |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | 2014-01-09 |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | 2013-08-02 |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | Chemtron Biotech, Inc. | 2013-05-30 |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. | 2012-07-17 |
| K112315 | HOME PREGNANCY TEST | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 |
| K102175 | RAPIDVUE HCG TEST | Quidel Corporation | 2010-08-25 |
| K072264 | FASTPACK HCG IMMUNOASSAY | Qualigen, Inc. | 2007-12-06 |
| K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC | Applied Dna Technologies, Inc. | 2007-06-29 |
| K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | Applied Dna Technologies, Inc. | 2007-06-29 |
| K061257 | DBEST HCG PANEL TEST KIT | Ameritek USA, Inc. | 2007-05-04 |
| K062361 | INNOVACON HCG UKTRA TEST DEVICE | Innovacon, Inc. | 2006-10-23 |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | Princeton BioMeditech Corp. | 2006-01-23 |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | Ind Diagnostic, Inc. | 2005-12-16 |
| K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | W.H.P.M., Inc. | 2005-08-22 |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | Ind Diagnostic, Inc. | 2005-05-16 |
| K043385 | OSOM HCG COMBO TEST | Genzyme Diagnostics | 2005-04-12 |
| K041946 | ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE | ACON Laboratories, Inc. | 2004-08-16 |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | Immunostics Inc., | 2004-08-11 |
| K033297 | ZAP HCG TEST, MODEL 8001 | Zbx Corporation | 2004-03-18 |
| K032563 | CLINITEST HCG PREGNANCY TEST | Bayer Healthcare, LLC | 2003-12-23 |
| K032987 | ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 | Unotech Diagnostics, Inc. | 2003-11-17 |
| K031445 | MAINLINE MAXIE HCG URINE PREGNANCY TEST | Mainline Technology, Inc. | 2003-07-01 |
| K031048 | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST | Access Bio Incorporate | 2003-06-16 |
| K023823 | EASYCUP | Zer Hitech | 2003-05-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10673486014020 | Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test | TECO DIAGNOSTICS | 2026-04-09 |
| 10673486014006 | Teco Diagnostics One-Step Pregnancy Dipstick Test | TECO DIAGNOSTICS | 2026-02-12 |
| 10850082766007 | QMedix™ | Diagnostic Automation, Inc. | 2025-12-24 |
| 20612479280162 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-12-10 |
| 20612479280148 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-12-10 |
| 20612479279722 | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-08-14 |
| 20612479279739 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-08-14 |
| 20197344024992 | Medline | MEDLINE INDUSTRIES, INC. | 2024-03-11 |
| 10850051158093 | Prabadin | Prabadin Corp | 2023-06-08 |
| 20888277703565 | Medline | MEDLINE INDUSTRIES, INC. | 2022-06-08 |
| 20888277703572 | Medline | MEDLINE INDUSTRIES, INC. | 2022-06-08 |
| 20885380181150 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-22 |
| 20885380181198 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-22 |
| 20885380181174 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-01-11 |
| 20885380181181 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-01-11 |
| 00630414293776 | Atellica IM ThCG | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| M90107RD70010 | QuickProfile™ HCG Test Strip | LUMIQUICK DIAGNOSTICS, INC. | 2017-11-15 |
| 08719481720728 | iProvèn | Masena Invest B.V. | 2017-06-23 |
| 00630414571263 | CLINITEK Status® Connector | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414572314 | CLINITEK Status®+ Analyzer | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414574639 | CLINITEK Status®+ Analyzer | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 10304040024123 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040024116 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040024109 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040024093 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 20885380020268 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-01 |
| 20885380020251 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-01 |
| 20885380020244 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-01 |
| 10885632116308 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-29 |
| 10885632116285 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-29 |