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 IFA: HEp-20-10 — EUROIMMUN Medizinische Labordiagnostika AGM. LVR Pack 4 WELL — SCIMEDX CORPORATIONANA Negative Control — Bion Enterprises, Ltd.ANA Scl-70 Control — Bion Enterprises, Ltd.Liquichek — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.nDNA Test Kit — ANTIBODIES INCORPORATEDAESKUSLIDES® ANA-HEp-2 gamma — Aesku.Diagnostics GmbH & Co. KGHELIOS — Aesku.Systems GmbH & Co. KGANA ACA Control — Bion Enterprises, Ltd.Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System — Bion Enterprises, Ltd.ANA(HEp2)120 Test(L) — SCIMEDX CORPORATIONLiquichek — BIO-RAD LABORATORIES, INC.MeDiCa — SCIMEDX CORPORATIONImmco Diagnostics Inc. — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.ANA R LVR 96 Test — SCIMEDX CORPORATIONANA(HEp2) 300 Test(L) — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IFA 40: HEp-20-10 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGAntinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System — Bion Enterprises, Ltd.ANA RNP Control — Bion Enterprises, Ltd.
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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