Product code CGI
- Device name
- Radioimmunoassay, Estriol
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1265
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974721 | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1998-03-03 |
| K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-23 |
| K955356 | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL | Diagnostic Systems Laboratories, Inc. | 1996-05-15 |
| K932989 | COAT-A-COUNT FREE ESTRIOL | Diagnostic Products Corp. | 1994-12-19 |
| K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | Wallac OY | 1994-12-09 |
| K920576 | AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL | Eastman Kodak Company | 1992-03-23 |
| K903359 | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT | Immunotech Corp. | 1990-08-22 |
| K860900 | IMMPULSE FREE ESTRIOL ASSAY REAGENTS | Sclavo, Inc. | 1986-04-28 |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | 1985-03-26 |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | Biotecx Laboratories, Inc. | 1985-02-01 |
| K844511 | TDX TOTAL ESTRIOL | Abbott Laboratories | 1985-01-18 |
| K844408 | AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED | Amersham Corp. | 1984-12-11 |
| K840902 | ENDAB ESTRIOL UNCONJUGATED | Immunotech Corp. | 1984-04-18 |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | New England Nuclear | 1984-03-30 |
| K830816 | DSL 1900 | Diagnostic Systems | 1983-04-12 |
| K823202 | FREE & TOTAL ESTRIOL KIT | Diagnostic Products Corp. | 1982-12-15 |
| K822578 | MICROMEDIC ESTRIOL RIA KIT | Micromedic Systems | 1982-10-26 |
| K822314 | DSL 1400 | Diagnostic Systems Laboratories, Inc. | 1982-09-30 |
| K821678 | AUTOPAK ESTRIOL TEST DELIVERY SYSTEM | Micromedic Systems | 1982-06-24 |
| K820728 | QUANTIMUNE ESTRIOL RIA | Bio-Rad | 1982-04-06 |
| K812768 | COAT-A-COUNT FREE & TOTAL ESTRIOL KIT | Diagnostic Products Corp. | 1982-01-18 |
| K811709 | QUANTIMUNE ESTRIOL RIA | Bio-Rad | 1981-07-10 |
| K811380 | ESTRIOL KIT | Cambridge Nuclear Corp. | 1981-06-09 |
| K811371 | NATAL-TEC ESTRIOL | Armkel, LLC | 1981-05-29 |
| K810667 | AMERLEX ESTRIOL RIA KIT | Amersham Corp. | 1981-03-31 |
| K802754 | IMMUNOREACTIVE ESTRIOL RIA KIT | Microanalytic Research, Inc. | 1981-01-21 |
| K802944 | QUANTIMUNE E3 RIA | Bio-Rad | 1980-12-22 |
| K802455 | ESTRIOL-SQUIBB RIA KIT | E. R. Squibb & Sons, Inc. | 1980-10-31 |
| K801735 | ARIA II 125- I-ESTRIOL SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-09-16 |
| K801424 | ESTRIOL RIA KIT FOR USE WITH GAMMAFLO | Squibb & Sons, Inc. | 1980-07-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850082766017 | AccuDiag™ Free Estriol ELISA | Diagnostic Automation, Inc. | 2026-01-27 |
| 04048474016123 | Free Estriol ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 04048474053517 | Free Estriol | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 00840239053510 | Free Estriol | DRG International Inc | 2023-08-26 |
| 00840239016126 | Free Estriol ELISA | DRG International Inc | 2023-08-23 |
| 04049016147602 | Free Estriol ELISA | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| B261CANE6400 | DBC Free Estriol ELISA | Diagnostics Biochem Canada Inc | 2022-11-15 |
| 00404847416121 | Free Estriol ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| B24220FE3HUE010 | Free Estriol ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| 00630414984452 | IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414997162 | IMMULITE® 2000 Systems UE3 Unconjugated Estriol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00816870021393 | uE3 AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021409 | uE3 AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022833 | uE3 AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022840 | uE3 AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 06438147355013 | AutoDELFIA Unconjugated Estriol (uE3) kit | Wallac Oy | 2018-11-16 |
| 06438147355037 | AutoDELFIA Unconjugated Estriol (uE3) kit | Wallac Oy | 2018-11-16 |
| 06438147119332 | AutoDELFIA Unconjugated Estriol (uE3) kit | Wallac Oy | 2016-06-01 |
| 06438147119745 | AutoDELFIA Unconjugated Estriol (uE3) kit | Wallac Oy | 2016-06-01 |