67 results
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34ms
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Sources: EU EUDAMED, US FDA
Applied BioCode, Inc.
FDA registration
Applied BioCode, Inc.·15 products·🇺🇸 United States
BioCode SA-PE Mix Pack
FDA UDI
APPLIED BIOCODE, INC.·00851034007042·Fluorescence dye for MDx 3000 assays.
BioCode Respiratory Pathogen Panel
FDA UDI
APPLIED BIOCODE, INC.·00851034007073·In-vitro multiplex assay used with the Biocode ...
BioCode 2500 Multiplex Detection System
FDA UDI
APPLIED BIOCODE, INC.·00851034007059·The BioCode 2500 Multiplex Detection System is ...
BioCode MDx 3000 Optical Calibration and Verification Kit
FDA UDI
APPLIED BIOCODE, INC.·00851034007028·Kit containing calibrators and controls for MDx...
BioCode MDx 3000
FDA UDI
APPLIED BIOCODE, INC.·00851034007004·The BioCode MDx 3000 is an automated molecular ...
BioCode MDx 3000 Buffer A
FDA UDI
APPLIED BIOCODE, INC.·00851034007035·Buffer used in MDx 3000 assays.
Gastrointestinal Pathogen Panel (GPP) Kit
FDA UDI
APPLIED BIOCODE, INC.·00851034007011·In-vitro multiplex assay used with the Biocode ...
5.0 X 14MM HA COATED IMPLANT
FDA Adverse Event
Other
·BICON, INC.·Product code DZE·December 4, 2001
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·August 15, 2012
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
BIOCODE SARS-COV-2 ASSAY KIT
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC·Product code QJR·April 20, 2021
BIOCODE SARS-COV-2 ASSAY KIT
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC·Product code QJR·April 20, 2021
BIOCODE SARS-COV-2 ASSAY KIT
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC·Product code QJR·April 20, 2021
BIOCODE SARS-COV-2 ASSAY KIT
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC·Product code QJR·April 20, 2021
BIOCODE SARS-COV-2 ASSAY KIT
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC·Product code QJR·April 20, 2021
BIOCODE SARS-COV-2 ASSAY KIT
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC·Product code OCC·April 20, 2021
BIOCODE® GASTROINTESTINAL PATHOGEN PANEL (GPP)
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC.·Product code PCH·June 27, 2022
TELL ME FAST NOVEL CORONAVIRUS (COVID-19) IGG/IGM AB TEST CASSETTE B251C
FDA Adverse Event
Malfunction
·BIOCAN DIAGNOSTICS INC.·Product code QKO·June 9, 2020
BIOCODE® MDX 3000
FDA Adverse Event
Malfunction
·APPLIED BIOCODE, INC.·Product code OOI·August 18, 2022