Ortho-Mune Ok-Comvo CD3-Fitc/CD8-Pe (Okt 3/OKT8) Monoclonal Antibody (Murine)
by Ortho Diagnostic Systems, Inc.
510(k) K950482
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950482 | Date10 May 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ortho-Mune OK-COMVO CD3-FITC/CD8-PE is a dual-conjugate monoclonal antibody reagent designed for the identification and enumeration of CD3+ and CD8+ human T lymphocytes. As a flow cytometry counter, it targets specific cell surface markers (CD3 and CD8) to differentiate T cell subsets in whole blood samples, enabling precise immunophenotyping. This device leverages murine-derived monoclonal antibodies conjugated with fluorescein isothiocyanate (FITC) and phycoerythrin (PE) for fluorescent labeling and detection. Its classification aligns with differential cell counters used in hematological analysis.
This reagent is supplied as a ready-to-use diagnostic tool for laboratory settings, requiring no additional processing beyond standard flow cytometry workflows. It is intended for single-use and must be stored under refrigeration to maintain stability and sterility. The device carries an FDA 510(k) clearance under the traditional pathway, classified as a Class II medical device (GKZ product code) and regulated under 21 CFR 864.5220. Compliance with hematology-specific standards ensures its use in clinical diagnostics for T cell subset analysis, adhering to established regulatory and procedural guidelines.
Other devices from Ortho Diagnostic Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Ortho-Mune OK-COMVO CD3-FITC/CD8-PE monoclonal antibody used for?
The Ortho-Mune OK-COMVO CD3-FITC/CD8-PE monoclonal antibody is designed for the identification and enumeration of CD3+ and CD8+ human T lymphocytes in whole blood samples. By targeting specific cell surface markers (CD3 and CD8), it enables precise immunophenotyping of T cell subsets, which is essential for diagnosing and monitoring hematological conditions.
How is the OK-COMVO CD3-FITC/CD8-PE reagent supplied and prepared for use?
The OK-COMVO CD3-FITC/CD8-PE reagent is supplied as a ready-to-use diagnostic tool, meaning no additional processing is required beyond standard flow cytometry workflows. It comes pre-conjugated with fluorescein isothiocyanate (FITC) and phycoerythrin (PE) for direct fluorescent labeling and detection, simplifying laboratory procedures.
Is the OK-COMVO CD3-FITC/CD8-PE monoclonal antibody single-use or reusable?
The Ortho-Mune OK-COMVO CD3-FITC/CD8-PE monoclonal antibody is intended for single-use only. This ensures sterility and reliability for each diagnostic procedure, reducing the risk of contamination or degradation over repeated use.
What storage conditions are required to maintain the stability and sterility of this reagent?
To maintain stability and sterility, the OK-COMVO CD3-FITC/CD8-PE monoclonal antibody must be stored under refrigeration. Proper refrigeration prevents degradation of the fluorescent conjugates and preserves the reagent’s performance for accurate T cell subset analysis.
What regulatory pathway and classification apply to the OK-COMVO CD3-FITC/CD8-PE monoclonal antibody?
The Ortho-Mune OK-COMVO CD3-FITC/CD8-PE monoclonal antibody has received FDA 510(k) clearance under the traditional pathway and is classified as a Class II medical device under product code GKZ. It is regulated under 21 CFR 864.5220, ensuring compliance with hematology-specific standards for clinical diagnostics.