1,417 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATHENA MULTILYTE
FDA Adverse Event
Malfunction
·WAMPOLE·Product code DHN·January 10, 2006
PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604
FDA Recall
Terminated
·Diasorin Inc.·Product code DHN·June 30, 2004
ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
FDA Recall
Terminated
·Immuno Concepts Inc·Product code DHN·December 4, 2008
Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code DHN·September 26, 2011
Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
FDA Recall
Terminated
·Perkinelmer Life Sciences, Inc.·Product code DHN·July 21, 2003
Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette".
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code DHN·July 29, 2008
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
FDA Recall
Terminated
·Diasorin Inc.·Product code DHN·September 24, 2004
"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code DHN·June 30, 2010
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
FDA classification
FDA Class 2
·Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
DEN TAG S.R.L.
FDA registration
DEN TAG S.R.L.·64 products·🇮🇹 Italy
DAN ALLEN SURGICAL
FDA registration
DAN ALLEN SURGICAL·3 products·🇺🇸 United States
DEN-MAT HOLDINGS, LLC
FDA registration
DEN-MAT HOLDINGS, LLC·42 products·🇺🇸 United States
AHN SURGICAL INNOVATION LLC
FDA registration
AHN SURGICAL INNOVATION LLC·1 product·🇺🇸 United States
Amvex Vacuum Regulator
FDA UDI
OHIO MEDICAL, LLC·00628101501273·VR-CH series, VacReg, Cont HIGH 760mmHg, Analo...
DAN MONOPOLAR LAP ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AHN DMEK RAKE
FDA UDI
KATENA PRODUCTS, INC.·00841668128985·AHN DMEK RAKE
SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
FDA UDI
DIO Corporation·08806195927502·SM Implant System is a root-form threaded denta...
TruBase
FDA UDI
Truabutment Korea Co.,Ltd·08800076420045·
SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
FDA UDI
DIO Corporation·08800049235348·SM Implant System is a root-form threaded denta...
SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
FDA UDI
DIO Corporation·08806195929384·SM Implant System is a root-form threaded denta...