LSKClass I
Dna-reagents, Chlamydia
Microbiology · 21 CFR 866.3120
MDR events5All time
Recalls1All time
Registered firms1Currently listed
510(k) clearances8All time
Recent MDR events
5 adverse event reports on file
- HYBRID CAPTURE 2 RAPID CAPTURE SYSTEMSep 13, 2002MalfunctionDigene Corp.1122376-2002-00003
- HYBRID CAPTURE 2 RAPID CAPTURE SYSTEMSep 13, 2002MalfunctionDigene Corp.1122376-2002-00002
- HYBRID CAPTURE 2 RAPID CAPTURE SYSTEMSep 13, 2002MalfunctionDigene Corp.1122376-2002-00001
- SURECELL CHLAMYDIA TEST KITFeb 26, 1997MalfunctionJohnson & Johnson Clinical Diagnostics1319520-1997-00003
- TESTPACK CHLAMYDIASep 27, 1996OtherAbbott Laboratories1451914-1996-00002
Event type breakdown
Malfunction4
Other1
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
1 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Abbott Molecular, Inc.May 28, 2010
K092704 · ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
- Digene Corp.Sep 25, 2001
K010891 · MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
- Digene Corp.Sep 24, 2001
K010892 · MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
- Digene Corp.Oct 25, 1999
K990023 · HYBRID CAPTURE II CT-ID TEST
- Gen-Probe, Inc.Apr 6, 1994
K920302 · PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
- Gen-Probe, Inc.Apr 29, 1992
K920378 · PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
- Gen-Probe, Inc.Dec 29, 1987
K874878 · GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
- Gen-Probe, Inc.Oct 28, 1987
K871878 · RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS