Albumin, Fitc, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting albumin using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based quantification of this major plasma protein in clinical specimens. Albumin measurement is used to assess nutritional status, liver function, and kidney disease. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DDZ, regulated under 21 CFR 866.5040, within the Immunology specialty.
Research product code DDZ 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
- DDZ
- Device Class
- FDA class 2
- Regulation Number
- 866.5040
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | Apr 21, 2005 | Substantially Equivalent | Good Biotech Corp. |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Apr 28, 2003 | Substantially Equivalent | Pointe Scientific, Inc., |
| K002674 | RANDOX MICROALBUMIN | Oct 05, 2000 | Substantially Equivalent | Randox Laboratories, Ltd. |
| K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | Jul 18, 1983 | Substantially Equivalent | Dako Corp. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.