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CD94-APC

Miltenyi Biotec B.V. & Co. KG · Model 170-081-033 · UDI-DI 04049934134265

MVU
0
510(k) clearances
74
Adverse events
43
Recalls
116
Facilities

Description

REA113 recognizes CD94, an approximately 45 kDa, single pass, type II transmembrane protein, which belongs to C-type lectin superfamily. CD94 associates covalently with NKG2 family members and forms disulfide-bonded heterodimers. CD94-NKG2 receptors bind HLA-E, the non-classical MHC class Ib molecule. Depending on the associated NKG2 member, CD94-NKG2 heterodimer transmits either activating or inhibitory signal. For example, via immunoreceptor tyrosine–based inhibitory motifs (ITIMs) containing NKG2A, CD94-NKG2A heterodimers inhibit NK cell cytotoxicity. Besides NK cells, expression of CD94-NKG2 heterodimers is also shown on NK-T cells and a small percentage of CD8 cells in mice, where the crosslinking of CD94-NKG2 was shown to reduce the level of spontaneous apoptosis. Additional Information: Clone REA113 displays negligible binding to Fc receptors.

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.