Haptoglobin, Fitc, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting and measuring haptoglobin, a serum protein that binds free hemoglobin and serves as a marker for hemolytic conditions. The kit uses FITC (fluorescein isothiocyanate) as a fluorescent conjugate and includes antigen, antiserum, and control components. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DAB, regulated under 21 CFR 866.5460, within the Immunology medical specialty.
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Basic Information
- Product Code
- DAB
- Device Class
- FDA class 2
- Regulation Number
- 866.5460
- 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 |
|---|---|---|---|---|
| K913670 | HAPTOGLOBIN IMMUNOLOGICAL TEST KIT | Dec 09, 1991 | Substantially Equivalent | The Binding Site, Ltd. |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | Oct 05, 1984 | Substantially Equivalent | Intl. Diagnostic Technology |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | Feb 03, 1978 | Substantially Equivalent | Gelman Instrument Co. |
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.