Enzyme Linked Immunosorbent Assay, T. Cruzi
Microbiology · 21 CFR 866.3870
Recent MDR events
46 adverse event reports on file
- ALINITY S CHAGASDec 9, 2019MalfunctionAbbott Germany3002809144-2019-01044
- ABBOTT PRISM CHAGASNov 25, 2019MalfunctionAbbott Laboratories1415939-2019-00221
- PRISM CHAGASFeb 15, 2019MalfunctionAbbott Laboratories1415939-2019-00010
- PRISM CHAGASAug 28, 2018MalfunctionAbbott Laboratories1415939-2018-00122
- PRISM CHAGASJul 23, 2018MalfunctionAbbott Laboratories1415939-2018-00113
- PRISM CHAGASJul 23, 2018MalfunctionAbbott Laboratories1415939-2018-00114
- ABBOTT ESA CHAGASMay 30, 2017MalfunctionAbbott Laboratories1415939-2017-00119
- PRISM CHAGASMay 26, 2017MalfunctionAbbott Laboratories1415939-2017-00117
- PRISM CHAGASMay 24, 2017MalfunctionAbbott Laboratories1415939-2017-00114
- PRISM CHAGASMar 24, 2017MalfunctionAbbott Laboratories1415939-2017-00027
Event type breakdown
Most-reported manufacturers
Registered firms
13 firms currently registered for this product code
Immunocentrix Corporation
Canoga Park, CA, US
Inbios International, Inc.
Seattle, WA, US
Chembio Diagnostic Systems
Bay Shore, NY, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Keva Inc.
Blaine, WA, US
Eiger Diagnostics, Inc.
Las Vegas, NV, US
Chembio Diagnostic Systems, Inc.
MEDFORD, NY, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
510(k) clearances
6 clearances for this product code
- InBios International, Inc.Dec 16, 2016
K161947 · Chagas Detect Plus Rapid Test
- Ortho-Clinical Diagnostics, Inc.Apr 15, 2009
K072732 · ORTHO T. CRUZI ELISA TEST SYSTEM
- Wiener Laboratories SaicFeb 11, 2004
K023889 · WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
- Hemagen Diagnostics, Inc.May 19, 1995
K930272 · HEMAGEN CHAGAS' KIT (EIA METHOD)
- Abbott LaboratoriesDec 19, 1994
K933716 · ABBOTT CHAGAS ANTIBODY EIA
- Gull Laboratories, Inc.May 4, 1992
K911233 · CHAGAS' IGG ELISA TEST