Kit, Serological, Positive Control
Clinical Chemistry · 21 CFR 862.1660
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
22 firms currently registered for this product code
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho Clinical Diagnostics
Singapore South West, SG
Abbott Laboratories
Lake Forest, IL, US
Abbott Gmbh
Wiesbaden Hesse, DE
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
Ctk Biotech, Inc.
Poway, CA, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Ortho-clinical Diagnostics
Pencoed Bridgend, GB
Lgc Clinical Diagnostics, Inc.
Milford, MA, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Minlong Pharmaceutical Biotechnology (shenzhen) Co., Ltd.
shenzhen Guangdong, CN
Sts Corporation
Duluth, GA, US
Aalto Scientific Ltd.
Eatonton, GA, US
510(k) clearances
7 clearances for this product code
- Aalto Scientific, Ltd.Jul 22, 2010
K101434 · AUDIT MICROCV PROCALCITONIN LINEARITY
- Ortho-Clinical DiagnosticsJan 17, 2003
K030067 · VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
- Scantibodies Laboratory, Inc.Dec 24, 1997
K974262 · SYSCOS IDC - G, IDC, BSC, IDC - G
- Boston Biomedica, Inc.Oct 8, 1997
K972986 · ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
- Simplicity Diagnostics, Inc.Mar 10, 1997
K970100 · TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
- Pb Diagnostic Systems, Inc.Mar 7, 1994
K934137 · OPUS(R) SEROLOGY CONTROLS, MODIFICATION
- Pb Diagnostics, Inc.Apr 8, 1993
K925703 · OPUS SEROLOGY CONTROLS