Complement C9, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Fujifilm Healthcare Manufacturing Corporation Mie Office
Komono-cho, Mie-gun, JP
The Binding Site
Kings Norton Birmingham, GB
Diasorin Inc.
Stillwater, MN, US
The Binding Site Group Ltd.
BIRMINGHAM, GB
Fujifilm Wako Pure Chemical Corporation Diagnostics Design Office (amagasaki)
Amagasaki-shi Hyogo, JP
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
510(k) clearances
6 clearances for this product code
- The Binding Site Group , Ltd.Aug 28, 2015
K150412 · Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
- The Binding Site Group , Ltd.Jul 11, 2012
K113349 · HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
- The Binding Site, Ltd.Sep 17, 1999
K992488 · TOTAL HAEMOLYTIC COMPLEMENT RID KIT
- Quidel Corp.Jul 29, 1998
K974111 · QUIDEL CH50 EQ EIA
- Wako Chemicals USA, Inc.Dec 18, 1995
K954145 · WAKO AUTOKIT CH50
- Incstar Corp.Oct 13, 1995
K951639 · COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)