Home › Device types › DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
FDA product code DHN · Class 2 · Immunology
126
Registered devices
1
Adverse events
7
Recalls
110
510(k) clearances
Devices with this code
ANA Homogeneous Control — Bion Enterprises, Ltd.IFA 40: HEp-20-10 — EUROIMMUN Medizinische Labordiagnostika AGLiquichek — BIO-RAD LABORATORIES, INC.ANA Negative Control — Bion Enterprises, Ltd.NOVA Lite® dsDNA Crithidia Luciliae — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONKallestad — Bio-RAD Laboratories, Inc.Kallestad — Bio-RAD Laboratories, Inc.ANA Scl-70 Control — Bion Enterprises, Ltd.ANA MS. LVR 48 Test — SCIMEDX CORPORATIONNOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI — INOVA DIAGNOSTICS, INC.ANA Test Kit — ANTIBODIES INCORPORATEDMeDiCa — SCIMEDX CORPORATIONM. LVR Pack 4 WELL — SCIMEDX CORPORATIONHEp2 12 Well Slide + control wells — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Liquichek — BIO-RAD LABORATORIES, INC.AESKUSLIDES® ANA-HEp-2 — Aesku.Diagnostics GmbH & Co. KGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System — Bion Enterprises, Ltd.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.ANA Calibrator — Bion Enterprises, Ltd.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-09-26 | Inova Diagnostics Incorporated | The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labe |
| 2010-06-30 | Bio-Rad Laboratories | KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides. |
| 2008-12-04 | Immuno Concepts Inc | Samples can occasionally run out of the wells and cross contaminate adjacent wells. |
| 2008-07-29 | Bio-Rad Laboratories | The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test |
| 2004-09-24 | Diasorin Inc. | A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered |
| 2004-06-30 | Diasorin Inc. | The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 |
| 2003-07-21 | Perkinelmer Life Sciences, Inc. | Product's outer carton label was labeled with an extended expiration date |
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