Fab, Rhodamine, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting the Fab fragment of immunoglobulins using rhodamine as a fluorescent conjugate, providing antigen, antiserum, and control components for immunofluorescence analysis of antibody structure in clinical and research laboratories. The Fab fragment contains the antigen-binding sites of the antibody. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is DBY, regulated under 21 CFR 866.5520, within the Immunology specialty.
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Basic Information
- Product Code
- DBY
- Device Class
- FDA class 1
- Regulation Number
- 866.5520
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022067 | CONVOY ADVANCED DELIVERY SHEATH | Sep 11, 2002 | Substantially Equivalent | Boston Scientific |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Feb 22, 2002 | Substantially Equivalent | Baylis Medical Co., Inc. |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | Jan 02, 2002 | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. |
| K013866 | CONVOY ADVANCED DELIVERY SHEATH KIT | Dec 14, 2001 | Substantially Equivalent | Boston Scientific |
| K013282 | GORE INTRODUCER SHEATH | Dec 14, 2001 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K771144 | RHODAMINE-CONJUGATED ANTISERUM | Jul 14, 1977 | Substantially Equivalent | Kent Laboratories, 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.