Antigens, Nontreponemal, All
Microbiology · 21 CFR 866.3820
Recent MDR events
35 adverse event reports on file
- BD BBL¿ VDRL ANTIGENJul 25, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00009
- BD MACRO-VUE¿ RPR CARD TESTMar 14, 2024MalfunctionBecton Dickinson Caribe Ltd.2647876-2024-00051
- BD MACRO-VUE¿ RPR CARD TESTJun 16, 2023MalfunctionBecton Dickinson Caribe Ltd.2647876-2023-00038
- BD MACRO-VUE¿ RPR CARD TESTMay 31, 2023MalfunctionBecton Dickinson Caribe Ltd.3008352382-2023-00090
- BD MACRO-VUE¿ RPR CARD TESTMay 31, 2023MalfunctionBecton Dickinson Caribe Ltd.3008352382-2023-00089
- BD MACRO-VUE¿ RPR CARD TESTMay 31, 2023MalfunctionBecton Dickinson Caribe Ltd.3008352382-2023-00091
- BD MACRO-VUE¿ RPR CARD TESTFeb 27, 2023MalfunctionBecton Dickinson Caribe Ltd.3008352382-2023-00006
- BD MACRO-VUE¿ RPR CARD TESTJan 11, 2023MalfunctionBecton Dickinson Caribe Ltd.3008352382-2023-00002
- BD MACRO-VUE¿ RPR CARD TESTDec 2, 2022MalfunctionBecton Dickinson Caribe Ltd.2647876-2022-00230
- BD MACRO-VUE¿ RPR CARD TESTNov 30, 2022MalfunctionBecton Dickinson Caribe Ltd.3008352382-2022-00011
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
29 firms currently registered for this product code
Teco Diagnostics
ANAHEIM, CA, US
Cenogenics Corp.
MORGANVILLE, NJ, US
Becton, Dickinson & Co.
SPARKS, MD, US
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Germaine Laboratories, Inc.
SAN ANTONIO, TX, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Axis-shield Diagnostics, Ltd.
DUNDEE Scotland, GB
Ksl Biomedical, Inc.
Buffalo, NY, US
Stanbio Laboratory
Boerne, TX, US
Zeus Scientific Llc
BRANCHBURG, NJ, US
Chembio Diagnostic Systems
Bay Shore, NY, US
Chembio Diagnostic Systems, Inc.
MEDFORD, NY, US
Gold Standard Diagnostics, Llc
Davis, CA, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
510(k) clearances
32 clearances for this product code
- Gold Standard Diagnostics, LLCOct 10, 2025
K250249 · Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- Arlington Scientific, Inc. (Asi)Oct 21, 2020
K201438 · ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
- Arlington Scientific, Inc. (Asi)Nov 30, 2018
K182391 · ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
- Arlington Scientific, Inc. (Asi)Jun 14, 2018
K173376 · ASI Evolution
- Gold Standard DiagnosticsNov 12, 2015
K150358 · Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- Beacon Biologicals, Inc.Jun 12, 2000
K000687 · THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
- Centers for Disease Control and PreventionFeb 23, 2000
K993633 · SYNTHETIC VDRL ANTIGEN
- Avanti Polar Lipids, Inc.Sep 20, 1999
K992124 · AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI