DHCClass II
System, Test, Systemic Lupus Erythematosus
Immunology · 21 CFR 866.5820
MDR events0All time
Recalls1All time
Registered firms8Currently listed
510(k) clearances16All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
8 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Corgenix, Inc.Apr 9, 2001
K001352 · REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
- Corgenix, Inc.Mar 30, 2001
K001398 · REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
- The Binding Site, Ltd.Mar 10, 1993
K930247 · HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
- Elias U.S.A., Inc.Mar 10, 1993
K930421 · ELIAS DSDNA ABS
- General Biometrics, Inc.Dec 9, 1991
K914801 · IMMUNOWELL DSDNA ANTIBODY TEST
- Lipogen, Inc.Jan 24, 1989
K885048 · ACCESS R-CLONE ANA PROFILE ASSAY
- Immunostics Co., Inc.Aug 12, 1987
K872910 · IMMUNO/SLE
- Texas Immunology, Inc.May 28, 1982
K821385 · SERO/TEX LE TEST