Panels › Immunology › Product code DHN · Class 2
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation 866.5100
0510(k)s in 12 months (110 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in DHN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2011 | Inova Diagnostics Incorporated Inova Diagnostic Inc., NOVA Lite ANA KSL Kit
Part Number: 708390. in vitro diagnostic. Terminated |
DHN | K901596 |
| Aug 22, 2011 | Bio-Rad Laboratories "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 d Terminated |
DHN | K813592 |
| Apr 6, 2009 | Immuno Concepts Inc 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, manufacture Terminated |
DHN | K803276 K833148 |
| Sep 19, 2008 | Bio-Rad Laboratories 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, Terminated |
DHN | K813592 |
| May 10, 2005 | Diasorin Inc. Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test. Terminated |
DHN | K822397 |
| Apr 6, 2005 | Diasorin Inc. 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 Tes Terminated |
DHN | K822397 |
| Aug 20, 2003 | Perkinelmer Life Sciences, Inc. Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use
Catalog Number: NEA 103 Terminated |
DHN | K843347 |
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