Iga, Fitc, Antigen, Antiserum, Control
The IgA, FITC, Antigen, Antiserum, Control test system (product code CZN) is an in-vitro diagnostic device used in immunology to detect or quantify immunoglobulin A (IgA) using a fluorescein isothiocyanate (FITC) fluorescent label in an immunofluorescence assay format, with antigen, antiserum, and control materials. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5510 in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CZN
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891683 | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | Apr 12, 1989 | Substantially Equivalent | Helena Laboratories |
| K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT | Feb 26, 1986 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K841815 | OPTIMATE IGA TEST | Jun 01, 1984 | Substantially Equivalent | Miles Laboratories, Inc. |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | Oct 31, 1983 | Substantially Equivalent | Gelco Diagnostics, Inc. |
| K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | Oct 28, 1983 | Substantially Equivalent | Gelco Diagnostics, Inc. |
| K831909 | RABBIT ANTISERUM TO HUMAN IGA | Jul 18, 1983 | Substantially Equivalent | Dako Corp. |
| K831607 | FIAX IGA TEST KIT | Jun 22, 1983 | Substantially Equivalent | Intl. Diagnostic Technology |
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.