Radioimmunoassay, Estriol
FDA product code CGI · Class I (low risk) · 21 CFR 862.1265 · Clinical Chemistry
42510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Amersham Corp. 4
- Bio-Rad 4
- Diagnostic Systems Laboratories, Inc. 3
- Diagnostic Products Corp. 3
- New England Nuclear 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Immunotech Corp. 2
- Cambridge Nuclear Corp. 2
- Micromedic Systems 2
- Bayer Corp. 1
- Diagnostic Systems 1
- Armkel, LLC 1
- Microanalytic Research, Inc. 1
- E. R. Squibb & Sons, Inc. 1
- Squibb & Sons, Inc. 1
- Nordiclab Intl. 1
- Radioassay Systems Laboratories, Inc. 1
- Clinical Assays, Inc. 1
- Immunalysis Corporation 1
- Wien Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974721 | Unconjugated Estriol Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)CGI · Traditional | Bayer Corp. | 03/03/1998SE |
| K962875 | Active Ultrasensitive Unconjugated Estriol EiaCGI · Traditional | Diagnostic Systems Laboratories, Inc. | 08/23/1996SE |
| K955356 | Active Ultra-Sensitive Unconjugated EstriolCGI · Traditional | Diagnostic Systems Laboratories, Inc. | 05/15/1996SE |
| K932989 | Coat-A-Count Free EstriolCGI · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K944490 | Autodelfia Unconjugated Estriol (UE3) KitCGI · Traditional | Wallac OY | 12/09/1994SE |
| K920576 | Amerlex-M High Sensitivity Unconjugated EstriolCGI · Traditional | Eastman Kodak Company | 03/23/1992SE |
| K903359 | Microzyme Unconjugated Estriol Enzyme Immuno KitCGI · Traditional | Immunotech Corp. | 08/22/1990SE |
| K860900 | Immpulse Free Estriol Assay ReagentsCGI · Traditional | Sclavo, Inc. | 04/28/1986SE |
| K850787 | Solid Phase Free Estriol Enzyme ImmunoassayCGI · Traditional | Nms Pharmaceuticals, Inc. | 03/26/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | Biotecx Laboratories, Inc. | 02/01/1985SE |
| K844511 | TDX Total EstriolCGI · Traditional | Abbott Laboratories | 01/18/1985SE |
| K844408 | Amerlex-M Specific Estriol UnconjugatedCGI · Traditional | Amersham Corp. | 12/11/1984SE |
| K840902 | Endab Estriol UnconjugatedCGI · Traditional | Immunotech Corp. | 04/18/1984SE |
| K840301 | Rianen Estriol Radioimmunoassay KitCGI · Traditional | New England Nuclear | 03/30/1984SE |
| K830816 | DSL 1900CGI · Traditional | Diagnostic Systems | 04/12/1983SE |
| K823202 | Free & Total Estriol KitCGI · Traditional | Diagnostic Products Corp. | 12/15/1982SE |
| K822578 | Micromedic Estriol Ria KitCGI · Traditional | Micromedic Systems | 10/26/1982SE |
| K822314 | DSL 1400CGI · Traditional | Diagnostic Systems Laboratories, Inc. | 09/30/1982SE |
| K821678 | Autopak Estriol Test Delivery SystemCGI · Traditional | Micromedic Systems | 06/24/1982SE |
| K820728 | Quantimune Estriol RiaCGI · Traditional | Bio-Rad | 04/06/1982SE |
| K812768 | Coat-A-Count Free & Total Estriol KitCGI · Traditional | Diagnostic Products Corp. | 01/18/1982SE |
| K811709 | Quantimune Estriol RiaCGI · Traditional | Bio-Rad | 07/10/1981SE |
| K811380 | Estriol KitCGI · Traditional | Cambridge Nuclear Corp. | 06/09/1981SE |
| K811371 | Natal-Tec EstriolCGI · Traditional | Armkel, LLC | 05/29/1981SE |
| K810667 | Amerlex Estriol Ria KitCGI · Traditional | Amersham Corp. | 03/31/1981SE |
| K802754 | Immunoreactive Estriol Ria KitCGI · Traditional | Microanalytic Research, Inc. | 01/21/1981SE |
| K802944 | Quantimune E3 RiaCGI · Traditional | Bio-Rad | 12/22/1980SE |
| K802455 | Estriol-Squibb Ria KitCGI · Traditional | E. R. Squibb & Sons, Inc. | 10/31/1980SE |
| K801735 | Aria II 125- I-Estriol SystemCGI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/16/1980SE |
| K801424 | Estriol Ria Kit for Use with GammafloCGI · Traditional | Squibb & Sons, Inc. | 07/21/1980SE |
| K800036 | Total Estriol Ria KitCGI · Traditional | Amersham Corp. | 01/21/1980SE |
| K792189 | Nordiclab Total Estriol Ria TestCGI · Traditional | Nordiclab Intl. | 11/13/1979SE |
| K791728 | Rsl's Assay Procedure QuantitationCGI · Traditional | Radioassay Systems Laboratories, Inc. | 09/27/1979SE |
| K790008 | I EstriolCGI · Traditional | Cambridge Nuclear Corp. | 02/26/1979SE |
| K781938 | Ria Kit, Gammadab EstriolCGI · Traditional | Clinical Assays, Inc. | 01/10/1979SE |
| K781850 | Ria, Quantimune E3CGI · Traditional | Bio-Rad | 01/03/1979SE |
| K781546 | Direct Estriol Ria KitCGI · Traditional | Immunalysis Corporation | 12/04/1978SE |
| K781599 | I-Estriol Test SetCGI · Traditional | Wien Laboratories, Inc. | 10/17/1978SE |
| K780016 | Human Follicle Stimulating HormoneCGI · Traditional | Pcl-Ria, Inc. | 02/03/1978SE |
| K772323 | Rianen Estriol Ria KitCGI · Traditional | New England Nuclear | 01/05/1978SE |
| K772215 | Unconjugated Estriol Ria KitCGI · Traditional | Amersham Corp. | 12/22/1977SE |
| K770465 | RIA-120 and Estriol Reagent SystemCGI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3006-2020 Class II | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol… | Beckman Coulter Inc. | 08/26/2020Terminated |
| Z-3023-2011 | Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated…The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access… | Beckman Coulter Inc. | 12/08/2009Terminated |