LSWClass II

Anti-dna Antibody, Antigen And Control

Immunology · 21 CFR 866.5100

MDR events5All time

Recalls1All time

Registered firms13Currently listed

510(k) clearances8All time

Recent MDR events

5 adverse event reports on file

SWIFT-LOCK ANCHORApr 11, 2019
InjurySt. Jude Medical - Neuromodulation1627487-2019-04380
LINOX SD 65/16Feb 19, 2013
MalfunctionBiotronik Se & Co. Kg1028232-2013-00384
HYBRID CAPTURE II CT-ID TESTMar 3, 2003
MalfunctionDigene Corporation1122376-2003-00014
PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.Dec 27, 2001
InjurySt. Jude Medical, Inc. Crmd2938836-2001-00455
Unnamed deviceSep 20, 1996
Injury2183460-1996-00007

Event type breakdown

Injury3

Malfunction2

Most-reported manufacturers

Unspecified1 Biotronik Se & Co. Kg1 Digene Corporation1 St. Jude Medical - Neuromodulation1 St. Jude Medical, Inc. Crmd1

Recalls

1 recall events for this product code

Phadia US Inc
TerminatedFeb 11, 2021
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in t
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
Z-1107-2021 · View FDA record ↗

Registered firms

13 firms currently registered for this product code

510(k) clearances

8 clearances for this product code