Product code MOI— Immunology
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
- Classification name
- System, Test, Immunological, Antigen, Tumor
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code MOI
FDA has cleared devices under product code MOI between 1997 and 2024, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2020
- 2019
- 2018
- 2011
- 2007
- 2004
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code MOI
Recent clearances under product code MOI
- K240403 — Access BR Monitor
- K233946 — IMMULITE® 2000 BR-MA
- K192524 — Lumipulse G CA15-3
- K193489 — ADVIA Centaur BR
- K192777 — ADVIA Centaur CA 15-3 assay
- K181492 — Elecsys CA 15-3 II
- K171605 — Elecsys CA 15-3 II
- K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
- K072612 — ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
- K042732 — ARCHITECT CA 15-3 ASSAY
- K033036 — BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
- K022178 — CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K013984 — IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
- K012357 — CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K010796 — AIA-PACK BRCA, ST AIA PACK BRCA
- K010588 — ELECSYSCA 15-3 II ASSAY
- K001468 — ELECSYS CA 15-3 TEST SYSTEM
- K983690 — VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
- K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
- K981698 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
- K980190 — ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
- K964703 — THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K964407 — IMX CA 15-3
- K965141 — TRUQUANT BR RIA
- K963926 — AXSYM CA 15-3
- K970695 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
- K971418 — CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
- K963803 — CENTOCOR CA 15-3 RIA MODEL NO. 800-033
Data sourced from openFDA. This site is unofficial and independent of the FDA.