Caltag CD4 R-PE Monoclonal Antibody

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K944128 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• CD3 Fitc/CD4 R-Pe Monoclonal Antibody Combination

  Class II

  FDA 510(k) K950918 Active Cleared 21 Dec 1995

• CD3 Fitc/CD19 R-Pe/CD45 Tri-Color Monoclonal Antibody Combination

  Class II

  FDA 510(k) K964856 Active Cleared 17 Jan 1997

• CD3 Fitc/CD4 R-Pe/CD45 Tri-Color Monoclonal Antibody Combination

  Class II

  FDA 510(k) K950919 Active Cleared 20 Dec 1995

• CD3 Fitc/CD8 R-Pe Monoclonal Antibody Combination

  Class II

  FDA 510(k) K950916 Active Cleared 21 Dec 1995

• Caltag CD8 Fitc and CD8 R-Pe Monoclonal Antibodies

  Class II

  FDA 510(k) K944126 Active Cleared 20 Jun 1995

• Caltag Fetal Hemoglobin Test

  Class II

  FDA 510(k) K990641 Active Cleared 17 Sep 1999

See all devices from Caltag Laboratories, Inc. →

• What is the primary use of the Caltag CD4 R-PE Monoclonal Antibody in a clinical setting?

  This reagent is specifically designed for identifying and quantifying CD4-positive cells in hematological samples. It uses a monoclonal antibody conjugated with R-Phycoerythrin (R-PE) fluorescence to enable precise enumeration of CD4 T-lymphocytes through flow cytometric analysis, which is essential for monitoring immune function, diagnosing HIV/AIDS, and assessing immune response in clinical and research settings.

• Is the Caltag CD4 R-PE Monoclonal Antibody intended for single-use or repeated use?

  The device is explicitly supplied as a ready-to-use diagnostic reagent for single-use applications in flow cytometry systems. It is not designed for reuse, and the manufacturer’s packaging ensures no additional sterilization is required beyond what is provided.

• How should the Caltag CD4 R-PE Monoclonal Antibody be stored to maintain its integrity?

  Storage conditions must follow the manufacturer’s instructions to preserve reagent integrity, though specific details (e.g., temperature ranges) are not provided in the data. Since it is a diagnostic reagent for in vitro use, proper handling—such as avoiding contamination or exposure to extreme temperatures—is critical to ensure accurate flow cytometric analysis.

• What regulatory pathway was followed for FDA clearance of this monoclonal antibody?

  The Caltag CD4 R-PE Monoclonal Antibody was cleared under the FDA 510(k) pathway (K944128) as a Class II device under regulation number 864.5220, with a decision of Substantially Equivalent (SESE). The submission was reviewed by the Hematology (HE) Advisory Committee and filed under product code GKZ, indicating its classification as a Counter, Differential Cell device.