FDA Product Code
FDA Product Code DHA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1155
510(k) Clearances — 72 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024-05-08 | Traditional | PDF ↗ |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 | Traditional | PDF ↗ |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023-06-05 | Traditional | PDF ↗ |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Laboratories | 2023-05-19 | Traditional | PDF ↗ |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022-12-27 | Traditional | PDF ↗ |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | Diazyme Laboratories, Inc. | 2021-12-13 | Traditional | PDF ↗ |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | 2021-08-18 | Traditional | PDF ↗ |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 | Traditional | PDF ↗ |
| K192547 | MAGLUMI 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 | Traditional | PDF ↗ |
| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 | Traditional | PDF ↗ |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017-10-23 | Traditional | PDF ↗ |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories | 2017-08-18 | Traditional | PDF ↗ |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials | Abbott Point of Care, Inc. | 2015-04-16 | Traditional | PDF ↗ |
| K130020 | ACCESS TOTAL BHCG (5TH IS) | Beckman Coulter, Inc. | 2013-10-01 | Traditional | PDF ↗ |
| K131037 | LIAISON XL HCG | DiaSorin, Inc. | 2013-09-06 | Traditional | PDF ↗ |
| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 | Traditional | PDF ↗ |
| K080094 | OLYMPUS TOTAL BHCG TEST SYSTEN | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 | Traditional | PDF ↗ |
| K063720 | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS | Ortho-Clinical Diagnostics | 2007-04-09 | Traditional | PDF ↗ |
| K063754 | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 | Dade Behring, Inc. | 2007-02-23 | Traditional | PDF ↗ |
| K060548 | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK | Dade Behring, Inc. | 2006-04-06 | Traditional | PDF ↗ |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | Nichols Institute Diagnostics | 2004-12-17 | Traditional | PDF ↗ |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Diagnostic Products Corp. | 2003-12-12 | Traditional | PDF ↗ |
| K031052 | CARESTART HCG ONE-STEP PREGNANCY TEST | Access Bio Incorporate | 2003-06-13 | Traditional | PDF ↗ |
| K022680 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) | Azog, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K022681 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) | Azog, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K013857 | AIMSTEP PREGNANCY | Germaine Laboratories, Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K013678 | VICTORCH MEDITEK'S HCG TEST CARD | Victorch Meditek, Inc. | 2001-12-27 | Traditional | PDF ↗ |
| K003696 | STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD | Dade Behring, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K003178 | ELECSYS HCG AND BETA TEST SYSTEM | Roche Diagnostics Corp. | 2000-12-14 | Traditional | PDF ↗ |
| K002148 | ELECSYS HCG TEST SYSTEM | Roche Diagnostics Corp. | 2000-08-22 | Traditional | PDF ↗ |
| K000844 | ABSOLUTE HCG PREGNANCY TEST | Mizuho USA, Inc. | 2000-06-16 | Traditional | PDF ↗ |
| K994085 | IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 | Diagnostic Products Corp. | 2000-01-28 | Traditional | PDF ↗ |
| K991532 | DRX QT. HCG | Metrika, Inc. | 1999-09-17 | Traditional | PDF ↗ |
| K991515 | INSURE PREGNANCY TEST | Inbios Intl., Inc. | 1999-05-28 | Traditional | PDF ↗ |
| K990222 | IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 | Diagnostic Products Corp. | 1999-02-26 | Traditional | PDF ↗ |
| K983424 | ABBOTT ARCHEITECT TOTAL B-HCG | Abbott Laboratories | 1998-12-01 | Traditional | PDF ↗ |
| K974512 | AIMSTICK PBD COMBO PREGNANCY | Germaine Laboratories, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K974368 | AIMSTICK PBD PREGNANCY | Germaine Laboratories, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | 1997-12-24 | Traditional | PDF ↗ |
| K973825 | MIDSTREAM HOME REGNANCY TEST | Germaine Laboratories, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-04-14 | Traditional | PDF ↗ |
| K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD | Dade Chemistry Systems, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K961792 | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS | Biocircuits Corp. | 1996-08-21 | Traditional | PDF ↗ |
| K961487 | ELECSYS HCG ASSAY | Boehringer Mannheim Corp. | 1996-06-12 | Traditional | PDF ↗ |
| K961351 | HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD | Bayer Corp. | 1996-06-03 | Traditional | PDF ↗ |
| K955707 | ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT | Excel Scientific, Inc. | 1996-05-02 | Traditional | PDF ↗ |
| K952283 | AMERLITE HCG-60 ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K945331 | AURAFLEX HCG | Organon Teknika Corp. | 1995-03-20 | Traditional | PDF ↗ |
| K950307 | BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | 1995-03-01 | Traditional | PDF ↗ |
| K941983 | SEALITE SCIENCES INC. | Sealite Sciences, Inc. | 1994-08-18 | Traditional | PDF ↗ |
| K941090 | UNISTEP HCG PREGNANCY TEST STRIP | Biotech Atlantic, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K932409 | SAS(TM) SERUM/URINE HCG | Sa Scientific, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K922073 | STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1992-10-19 | Traditional | PDF ↗ |
| K913236 | STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1991-08-16 | Traditional | PDF ↗ |
| K911796 | IMMULITE(TM) HCG | Cirrus Diagnostics, Inc. | 1991-06-20 | Traditional | PDF ↗ |
| K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST | Ampcor, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K893953 | ABSOLUTE(TM)-HCG URINE PREGNANCY TEST | Totem Diagnostics, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K893577 | STATUS HCG FLUOROMETRIC ENZYME | Baxter Healthcare Corp | 1989-08-03 | Traditional | PDF ↗ |
| K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST | Princeton Biomedix | 1989-06-19 | Traditional | PDF ↗ |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Leeco Diagnostics, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Leeco Diagnostics, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K884430 | SERUM HCG MICROASSAY | Diamedix Corp. | 1988-12-09 | Traditional | PDF ↗ |
| K883148 | IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 | Diagnostic Chemicals, Ltd. (Usa) | 1988-12-05 | Traditional | PDF ↗ |
| K884207 | RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO | Abbott Laboratories | 1988-12-02 | Traditional | PDF ↗ |
| K882192 | HYGEIA URINE PREGNANCY TEST | Hygeia Sciences | 1988-11-10 | Traditional | PDF ↗ |
| K882896 | ONE-STEP HCG | Wampole Laboratories | 1988-10-31 | Traditional | PDF ↗ |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | Pacific Biotech, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K883235 | RAPIDTEST-HCG (TM) | Synbiotics Corp. | 1988-09-30 | Traditional | PDF ↗ |
| K880678 | MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY | Ventrex Laboratories, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K873986 | BETA-HCG ASSAY | Schiff & Co. | 1988-02-02 | Traditional | PDF ↗ |
| K873872 | HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 | Medix Biotech, Inc. | 1987-10-28 | Traditional | PDF ↗ |
| K862108 | ENZYMUN-TEST HCG | Boehringer Mannheim Corp. | 1986-08-19 | Traditional | PDF ↗ |
Product code DHA · Class II · Clinical Chemistry. Data: openFDA.