127 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
BD PROBETEC ET
FDA Adverse Event
BECTON DICKINSON AND CO·Product code LIO·May 30, 2002
BD PROBETEC ET INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code KHO·July 24, 2003
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 15, 2013
BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MKZ·September 29, 2010
BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL
FDA Adverse Event
Injury
·BD DIAGNOSTICS·Product code LSL·February 23, 2009
BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL
FDA Adverse Event
Injury
·BD DIAGNOSTICS·Product code LSL·February 23, 2009
BD PROBETEC ET CT/GC COLLECTION KIT FOR ENDO
FDA Adverse Event
Other
·PURITAN MEDICAL PRODUCTS CO LLC·Product code LIO·December 6, 2007
BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL
FDA Adverse Event
Other
·PURITAN MEDICAL PRODUCTS CO. LLC.·Product code LSL·January 8, 2009
CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LSL·March 18, 2024
CONTROL SET FOR THE BD PROBETEC (CT/GC) QX AMPLIFIED DNA ASSAYS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LSL·February 10, 2021
Sentimag SMC02 Probe Test Phantom
FDA UDI
ENDOMAGNETICS LTD·15060391210039·Part of the Sentimag system, it is to be used i...
BD ProbeTec™ Trichomonas vaginalis
FDA UDI
BECTON, DICKINSON AND COMPANY·00382904434335·Kit TV QX Assay 384 Reagent Test Pack
BD ProbeTec™ ET Pipettor
FDA UDI
BECTON, DICKINSON AND COMPANY·00382904404871·BD ProbeTec™ ET Pipettor
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
FDA 510(k)
FDA Class 2
·Microbiology
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·May 9, 2012
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORP·Product code GEI·April 3, 2015
BD ProbeTec™ ET Control Set
FDA UDI
BECTON, DICKINSON AND COMPANY·00382904404512·Set CT/GC Control