Immunoassay, Insulin-like Growth Factor Binding Protein-1
Clinical Chemistry · 21 CFR 862.1550
The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
Recent MDR events
7 adverse event reports on file
- ACTIMPROM POC TEST 10/BOXMar 25, 2021MalfunctionCoopersurgical Inc.1216677-2021-00047
- ACTIMPROM POC TEST 10/BOXMar 25, 2021MalfunctionCoopersurgical Inc.1216677-2021-00046
- ACTIMPROM POC TEST 10/BOXJan 5, 2021MalfunctionCoopersurgical Inc.1216677-2020-00310
- ACTIMPROM POC TEST 10/BOXDec 14, 2020MalfunctionCoopersurgical Inc.1216677-2020-00300
- ACTIMPROM POC TEST 10/BOXDec 4, 2020MalfunctionCoopersurgical Inc.1216677-2020-00288
- ACTIMPROM CONTROL TESTOct 22, 2020MalfunctionCoopersurgical Inc.1216677-2020-00241
- IMMULITE 2000Mar 4, 2013MalfunctionSiemens Healthcare Diagnostics2247117-2013-00023
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
12 firms currently registered for this product code
Bioteke Corporation (wuxi) Co., Ltd
Wuxi City Jiangsu, CN
Diasource Immunoassays, Sa
Louvain-La-Neuve Brabant Wallon, BE
Jiangsu Macro & Micro-test Med-tech Co., Ltd.
Nantong Jiangsu, CN
Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Wuxi Jiangsu, CN
Actim Oy
Espoo Uusimaa, FI
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Ave Science & Technology Co., Ltd
Changsha Hunan, CN
Actim Oy Manufacturing Site
Joensuu Pohjois-Karjala, FI
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Immunodiagnostic Systems Ltd.
Boldon Colliery Durham, GB
Aceso Laboratories Inc.
Chino, CA, US
Acro Biotech Inc.
Montclair, CA, US
510(k) clearances
2 clearances for this product code