CGI · Radioimmunoassay, Estriol
Clinical Chemistry · 21 CFR 862.1265 · Class 1
Overview
| Product Code | CGI |
|---|---|
| Device Name | Radioimmunoassay, Estriol |
| Regulation | 21 CFR 862.1265 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974721 | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | Mar 3, 1998 | SESE |
| K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | Diagnostic Systems Laboratories, Inc. | Aug 23, 1996 | SESE |
| K955356 | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL | Diagnostic Systems Laboratories, Inc. | May 15, 1996 | SESE |
| K932989 | COAT-A-COUNT FREE ESTRIOL | Diagnostic Products Corp. | Dec 19, 1994 | SESE |
| K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | Wallac OY | Dec 9, 1994 | SESE |
| K920576 | AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL | Eastman Kodak Company | Mar 23, 1992 | SESE |
| K903359 | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT | Immunotech Corp. | Aug 22, 1990 | SESE |
| K860900 | IMMPULSE FREE ESTRIOL ASSAY REAGENTS | Sclavo, Inc. | Apr 28, 1986 | SESE |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | Mar 26, 1985 | SESE |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | Biotecx Laboratories, Inc. | Feb 1, 1985 | SESE |
| K844511 | TDX TOTAL ESTRIOL | Abbott Laboratories | Jan 18, 1985 | SESE |
| K844408 | AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED | Amersham Corp. | Dec 11, 1984 | SESE |
| K840902 | ENDAB ESTRIOL UNCONJUGATED | Immunotech Corp. | Apr 18, 1984 | SESE |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | New England Nuclear | Mar 30, 1984 | SESE |
| K830816 | DSL 1900 | Diagnostic Systems | Apr 12, 1983 | SESE |
| K823202 | FREE & TOTAL ESTRIOL KIT | Diagnostic Products Corp. | Dec 15, 1982 | SESE |
| K822578 | MICROMEDIC ESTRIOL RIA KIT | Micromedic Systems | Oct 26, 1982 | SESE |
| K822314 | DSL 1400 | Diagnostic Systems Laboratories, Inc. | Sep 30, 1982 | SESE |
| K821678 | AUTOPAK ESTRIOL TEST DELIVERY SYSTEM | Micromedic Systems | Jun 24, 1982 | SESE |
| K820728 | QUANTIMUNE ESTRIOL RIA | Bio-Rad | Apr 6, 1982 | SESE |
Top Applicants
- Amersham Corp. — 4 clearances
- Bio-Rad — 4 clearances
- Diagnostic Products Corp. — 3 clearances
- Diagnostic Systems Laboratories, Inc. — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
