Hemopexin, Antigen, Antiserum, Control
This is an immunological reagent kit for the detection and measurement of hemopexin, a plasma glycoprotein that scavenges free heme in circulation, preventing heme-mediated toxicity. The kit includes antigen, antiserum, and control components for use in laboratory immunoassays. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is CZX, regulated under 21 CFR 866.5490, within the Immunology medical specialty.
Basic Information
- Product Code
- CZX
- Device Class
- FDA class 2
- Regulation Number
- 866.5490
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K801432 | HEMOPEXIN NEPHELOMETRIC ASSAY | Jul 08, 1980 | Substantially Equivalent | J.T. Baker Chemical Co. |
| K790713 | ANTISERUM TO HUMAN HEMOPEXIN | Sep 04, 1979 | Substantially Equivalent | Kent Laboratories, Inc. |
| K780250 | HEMOPEXIN NEPHELOMETRIC ASSAYS | Feb 28, 1978 | Substantially Equivalent | Kallestad Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.