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CD34-VioBlue

Miltenyi Biotec B.V. & Co. KG · Model 170-081-079 · UDI-DI 04049934133800

MVU
0
510(k) clearances
74
Adverse events
43
Recalls
118
Facilities

Description

AC136 recognizes the human CD34, a class III epitope of the CD34 antigen. This epitope is different than the one recognized by the clone used in the CD34 MicroBead Kits. The CD34 antigen is a single-chain transmembrane glycoprotein, expressed on human hematopoietic stem and progenitor cells, endothelial progenitor cells, vascular endothelial cells, embryonic fibroblasts, and some cells in fetal and adult nervous tissue. The antigen is absent on fully differentiated hematopoietic cells, such as normal peripheral blood lymphocytes, monocytes, granulocytes, erythrocytes, and platelets. Clone AC136 has a similar specificity as the CD34 monoclonal antibody clone 8G12 (HPCA-2). CD34 antibodies can be used for studies of hematopoiesis and nonhematopoietic stem cells, phenotyping of hematopoietic stem cells, and studies on phenotyping of hematologic malignancies, endothelial cells, and endothelial progenitor cells (EPCs).

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2024-11-01Kreatech Biotechnology BvThe 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
2024-02-01Abbott 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.
2023-10-25Becton, Dickinson and Company, BD BiosciencesIn 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
2023-05-24Cytocell Ltd.DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2023-05-24Cytocell Ltd.DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2022-10-27Cytocell 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
2022-10-27Cytocell 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
2022-03-25Becton, Dickinson and Company, BD BiosciencesAnti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
2022-03-25Becton, Dickinson and Company, BD BiosciencesAnti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.