11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·July 10, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 21, 2024
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 13, 2018
ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 13, 2018
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024