Complement C9, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting complement C9, the terminal component of the membrane attack complex that polymerizes to form pores in target cell membranes. The kit includes antigen, antiserum, and control components for in vitro diagnostic testing in clinical immunology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAE, regulated under 21 CFR 866.5240, within the Immunology specialty.
Research product code DAE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DAE
- Device Class
- FDA class 2
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | Aug 28, 2015 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO | Jul 11, 2012 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K992488 | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | Sep 17, 1999 | Substantially Equivalent | The Binding Site, Ltd. |
| K974111 | QUIDEL CH50 EQ EIA | Jul 29, 1998 | Substantially Equivalent | Quidel Corp. |
| K954145 | WAKO AUTOKIT CH50 | Dec 18, 1995 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | Oct 13, 1995 | Substantially Equivalent | Incstar Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.