CD13-PE
Miltenyi Biotec B.V. & Co. KG · Model 170-081-019 · UDI-DI 04049934134401
Description
REA263 recognizes the CD13 antigen, a 150–170 kDa type II transmembrane glycoprotein, which is also known as aminopeptidase N or gp150. CD13 is expressed on granulocytes, myeloid progenitors, endothelial cells, epithelial cells, and subset of granular lymphoid cells. It is also broadly expressed in other tissues such as kidney proximal tubules, intestine, and placenta. CD13 is an enzyme that is used as a biomarker to detect damage to the kidneys, and that may be used to help diagnose certain kidney disorders. It also serves as a receptor for one strain of human coronavirus that is an important cause of upper respiratory tract infections. Defects in CD13 appear to be a cause of various types of leukemia or lymphoma. Additional information: Clone REA263 displays negligible binding to Fc receptors.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-11-01 | Kreatech Biotechnology Bv | The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be |
| 2024-02-01 | Abbott Molecular, Inc. | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. |
| 2023-10-25 | Becton, Dickinson and Company, BD Biosciences | In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis |
| 2023-05-24 | Cytocell Ltd. | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| 2023-05-24 | Cytocell Ltd. | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| 2022-10-27 | Cytocell Ltd. | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device |
| 2022-10-27 | Cytocell Ltd. | An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using t |
| 2022-03-25 | Becton, Dickinson and Company, BD Biosciences | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. |
| 2022-03-25 | Becton, Dickinson and Company, BD Biosciences | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs