Product Code: CGI FDA class 1 21 CFR 862.1265

Radioimmunoassay, Estriol

Clinical Chemistry

The Radioimmunoassay, Estriol test system (product code CGI) is an in-vitro diagnostic device used in clinical chemistry to measure estriol, an estrogen produced primarily during pregnancy, in serum or urine using a radioimmunoassay technique. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1265 in the Clinical Chemistry medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code CGI in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: CGI
Device Class: FDA class 1
Regulation Number: 862.1265
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974721	UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	Mar 03, 1998	Substantially Equivalent	Bayer Corp.
K962875	ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA	Aug 23, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K955356	ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL	May 15, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K932989	COAT-A-COUNT FREE ESTRIOL	Dec 19, 1994	Substantially Equivalent	Diagnostic Products Corp.
K944490	AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT	Dec 09, 1994	Substantially Equivalent	Wallac OY
K920576	AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL	Mar 23, 1992	Substantially Equivalent	Eastman Kodak Company
K903359	MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT	Aug 22, 1990	Substantially Equivalent	Immunotech Corp.
K860900	IMMPULSE FREE ESTRIOL ASSAY REAGENTS	Apr 28, 1986	Substantially Equivalent	Sclavo, Inc.
K850787	SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY	Mar 26, 1985	Substantially Equivalent	Nms Pharmaceuticals, Inc.
K844767	RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO	Feb 01, 1985	Substantially Equivalent	Biotecx Laboratories, Inc.
K844511	TDX TOTAL ESTRIOL	Jan 18, 1985	Substantially Equivalent	Abbott Laboratories
K844408	AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED	Dec 11, 1984	Substantially Equivalent	Amersham Corp.
K840902	ENDAB ESTRIOL UNCONJUGATED	Apr 18, 1984	Substantially Equivalent	Immunotech Corp.
K840301	RIANEN ESTRIOL RADIOIMMUNOASSAY KIT	Mar 30, 1984	Substantially Equivalent	New England Nuclear
K830816	DSL 1900	Apr 12, 1983	Substantially Equivalent	Diagnostic Systems
K823202	FREE & TOTAL ESTRIOL KIT	Dec 15, 1982	Substantially Equivalent	Diagnostic Products Corp.
K822578	MICROMEDIC ESTRIOL RIA KIT	Oct 26, 1982	Substantially Equivalent	Micromedic Systems
K822314	DSL 1400	Sep 30, 1982	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K821678	AUTOPAK ESTRIOL TEST DELIVERY SYSTEM	Jun 24, 1982	Substantially Equivalent	Micromedic Systems
K820728	QUANTIMUNE ESTRIOL RIA	Apr 06, 1982	Substantially Equivalent	Bio-Rad
K812768	COAT-A-COUNT FREE & TOTAL ESTRIOL KIT	Jan 18, 1982	Substantially Equivalent	Diagnostic Products Corp.
K811709	QUANTIMUNE ESTRIOL RIA	Jul 10, 1981	Substantially Equivalent	Bio-Rad
K811380	ESTRIOL KIT	Jun 09, 1981	Substantially Equivalent	Cambridge Nuclear Corp.
K811371	NATAL-TEC ESTRIOL	May 29, 1981	Substantially Equivalent	Armkel, LLC
K810667	AMERLEX ESTRIOL RIA KIT	Mar 31, 1981	Substantially Equivalent	Amersham Corp.
K802754	IMMUNOREACTIVE ESTRIOL RIA KIT	Jan 21, 1981	Substantially Equivalent	Microanalytic Research, Inc.
K802944	QUANTIMUNE E3 RIA	Dec 22, 1980	Substantially Equivalent	Bio-Rad
K802455	ESTRIOL-SQUIBB RIA KIT	Oct 31, 1980	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K801735	ARIA II 125- I-ESTRIOL SYSTEM	Sep 16, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K801424	ESTRIOL RIA KIT FOR USE WITH GAMMAFLO	Jul 21, 1980	Substantially Equivalent	Squibb & Sons, Inc.
K800036	TOTAL ESTRIOL RIA KIT	Jan 21, 1980	Substantially Equivalent	Amersham Corp.
K792189	NORDICLAB TOTAL ESTRIOL RIA TEST	Nov 13, 1979	Substantially Equivalent	Nordiclab Intl.
K791728	RSL'S ASSAY PROCEDURE QUANTITATION	Sep 27, 1979	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K790008	I ESTRIOL	Feb 26, 1979	Substantially Equivalent	Cambridge Nuclear Corp.
K781938	RIA KIT, GAMMADAB ESTRIOL	Jan 10, 1979	Substantially Equivalent	Clinical Assays, Inc.
K781850	RIA, QUANTIMUNE E3	Jan 03, 1979	Substantially Equivalent	Bio-Rad
K781546	DIRECT ESTRIOL RIA KIT	Dec 04, 1978	Substantially Equivalent	Immunalysis Corporation
K781599	I-ESTRIOL TEST SET	Oct 17, 1978	Substantially Equivalent	Wien Laboratories, Inc.
K780016	HUMAN FOLLICLE STIMULATING HORMONE	Feb 03, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K772323	RIANEN ESTRIOL RIA KIT	Jan 05, 1978	Substantially Equivalent	New England Nuclear
K772215	UNCONJUGATED ESTRIOL RIA KIT	Dec 22, 1977	Substantially Equivalent	Amersham Corp.
K770465	RIA-120 AND ESTRIOL REAGENT SYSTEM	Jun 02, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic