Complement C1s, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting complement C1s, a serine protease that forms part of the C1 complex and plays a key role in activation of the classical complement pathway. The kit includes antigen, antiserum, and control components for in vitro diagnostic use. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is CZY, regulated under 21 CFR 866.5240, within the Immunology specialty.
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Basic Information
- Product Code
- CZY
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874379 | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | Nov 25, 1987 | Substantially Equivalent | Cytotech, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.