Radioimmunoassay, Estriol

FDA product code CGI · 42 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1265
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-06-02 – 1998-03-03

CGI 1998-03-03

UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K974721

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CGI 1996-08-23

ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA

Applicant Diagnostic Systems Laboratories, Inc.

K number K962875

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CGI 1996-05-15

ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL

Applicant Diagnostic Systems Laboratories, Inc.

K number K955356

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CGI 1994-12-19

COAT-A-COUNT FREE ESTRIOL

Applicant Diagnostic Products Corp.

K number K932989

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CGI 1994-12-09

AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT

Applicant Wallac OY

K number K944490

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CGI 1992-03-23

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL

Applicant Eastman Kodak Company

K number K920576

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CGI 1990-08-22

MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT

Applicant Immunotech Corp.

K number K903359

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CGI 1986-04-28

IMMPULSE FREE ESTRIOL ASSAY REAGENTS

Applicant Sclavo, Inc.

K number K860900

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CGI 1985-03-26

SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY

Applicant Nms Pharmaceuticals, Inc.

K number K850787

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CGI 1985-02-01

RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO

Applicant Biotecx Laboratories, Inc.

K number K844767

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CGI 1985-01-18

TDX TOTAL ESTRIOL

Applicant Abbott Laboratories

K number K844511

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CGI 1984-12-11

AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED

Applicant Amersham Corp.

K number K844408

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CGI 1984-04-18

ENDAB ESTRIOL UNCONJUGATED

Applicant Immunotech Corp.

K number K840902

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CGI 1984-03-30

RIANEN ESTRIOL RADIOIMMUNOASSAY KIT

Applicant New England Nuclear

K number K840301

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CGI 1983-04-12

DSL 1900

Applicant Diagnostic Systems

K number K830816

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CGI 1982-12-15

FREE & TOTAL ESTRIOL KIT

Applicant Diagnostic Products Corp.

K number K823202

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CGI 1982-10-26

MICROMEDIC ESTRIOL RIA KIT

Applicant Micromedic Systems

K number K822578

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CGI 1982-09-30

DSL 1400

Applicant Diagnostic Systems Laboratories, Inc.

K number K822314

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CGI 1982-06-24

AUTOPAK ESTRIOL TEST DELIVERY SYSTEM

Applicant Micromedic Systems

K number K821678

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CGI 1982-04-06

QUANTIMUNE ESTRIOL RIA

Applicant Bio-Rad

K number K820728

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CGI 1982-01-18

COAT-A-COUNT FREE & TOTAL ESTRIOL KIT

Applicant Diagnostic Products Corp.

K number K812768

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CGI 1981-07-10

QUANTIMUNE ESTRIOL RIA

Applicant Bio-Rad

K number K811709

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CGI 1981-06-09

ESTRIOL KIT

Applicant Cambridge Nuclear Corp.

K number K811380

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CGI 1981-05-29

NATAL-TEC ESTRIOL

Applicant Armkel, LLC

K number K811371

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CGI 1981-03-31

AMERLEX ESTRIOL RIA KIT

Applicant Amersham Corp.

K number K810667

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CGI 1981-01-21

IMMUNOREACTIVE ESTRIOL RIA KIT

Applicant Microanalytic Research, Inc.

K number K802754

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CGI 1980-12-22

QUANTIMUNE E3 RIA

Applicant Bio-Rad

K number K802944

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CGI 1980-10-31

ESTRIOL-SQUIBB RIA KIT

Applicant E. R. Squibb & Sons, Inc.

K number K802455

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CGI 1980-09-16

ARIA II 125- I-ESTRIOL SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K801735

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CGI 1980-07-21

ESTRIOL RIA KIT FOR USE WITH GAMMAFLO

Applicant Squibb & Sons, Inc.

K number K801424

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CGI 1980-01-21

TOTAL ESTRIOL RIA KIT

Applicant Amersham Corp.

K number K800036

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CGI 1979-11-13

NORDICLAB TOTAL ESTRIOL RIA TEST

Applicant Nordiclab Intl.

K number K792189

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CGI 1979-09-27

RSL'S ASSAY PROCEDURE QUANTITATION

Applicant Radioassay Systems Laboratories, Inc.

K number K791728

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CGI 1979-02-26

I ESTRIOL

Applicant Cambridge Nuclear Corp.

K number K790008

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CGI 1979-01-10

RIA KIT, GAMMADAB ESTRIOL

Applicant Clinical Assays, Inc.

K number K781938

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CGI 1979-01-03

RIA, QUANTIMUNE E3

Applicant Bio-Rad

K number K781850

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CGI 1978-12-04

DIRECT ESTRIOL RIA KIT

Applicant Immunalysis Corporation

K number K781546

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CGI 1978-10-17

I-ESTRIOL TEST SET

Applicant Wien Laboratories, Inc.

K number K781599

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CGI 1978-02-03

HUMAN FOLLICLE STIMULATING HORMONE

Applicant Pcl-Ria, Inc.

K number K780016

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CGI 1978-01-05

RIANEN ESTRIOL RIA KIT

Applicant New England Nuclear

K number K772323

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CGI 1977-12-22

UNCONJUGATED ESTRIOL RIA KIT

Applicant Amersham Corp.

K number K772215

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CGI 1977-06-02

RIA-120 AND ESTRIOL REAGENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K770465

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