Product code CGI— Clinical Chemistry
QUANTIMUNE ESTRIOL RIA
- Classification name
- Radioimmunoassay, Estriol
- Device class
- Class 1
- Regulation
- 21 CFR 862.1265
- Advisory panel
- Clinical Chemistry
- Total cleared
- 42
- First cleared
- Most recent
Market context for product code CGI
FDA has cleared devices under product code CGI between 1977 and 1998, filed by 27 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 1998
- 1996
- 1994
- 1992
- 1990
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
- 1980
- 1979
- 1978
- 1977
Top applicants under product code CGI
Recent clearances under product code CGI
- K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
- K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
- K932989 — COAT-A-COUNT FREE ESTRIOL
- K944490 — AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
- K920576 — AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
- K903359 — MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
- K860900 — IMMPULSE FREE ESTRIOL ASSAY REAGENTS
- K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
- K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
- K844511 — TDX TOTAL ESTRIOL
- K844408 — AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
- K840902 — ENDAB ESTRIOL UNCONJUGATED
- K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
- K830816 — DSL 1900
- K823202 — FREE & TOTAL ESTRIOL KIT
- K822578 — MICROMEDIC ESTRIOL RIA KIT
- K822314 — DSL 1400
- K821678 — AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
- K820728 — QUANTIMUNE ESTRIOL RIA
- K812768 — COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
- K811709 — QUANTIMUNE ESTRIOL RIA
- K811380 — ESTRIOL KIT
- K811371 — NATAL-TEC ESTRIOL
- K810667 — AMERLEX ESTRIOL RIA KIT
- K802754 — IMMUNOREACTIVE ESTRIOL RIA KIT
- K802944 — QUANTIMUNE E3 RIA
- K802455 — ESTRIOL-SQUIBB RIA KIT
- K801735 — ARIA II 125- I-ESTRIOL SYSTEM
- K801424 — ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
- K800036 — TOTAL ESTRIOL RIA KIT
- K792189 — NORDICLAB TOTAL ESTRIOL RIA TEST
- K791728 — RSL'S ASSAY PROCEDURE QUANTITATION
- K790008 — I ESTRIOL
- K781938 — RIA KIT, GAMMADAB ESTRIOL
- K781850 — RIA, QUANTIMUNE E3
- K781546 — DIRECT ESTRIOL RIA KIT
- K781599 — I-ESTRIOL TEST SET
- K780016 — HUMAN FOLLICLE STIMULATING HORMONE
- K772323 — RIANEN ESTRIOL RIA KIT
- K772215 — UNCONJUGATED ESTRIOL RIA KIT
- K770465 — RIA-120 AND ESTRIOL REAGENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.