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Reagents, Specific, Analyte
FDA product code MVU · Class 1 · Pathology
8,374
Registered devices
74
Adverse events
43
Recalls
0
510(k) clearances
Devices with this code
CytoCell — CYTOCELL LIMITEDHelicobacter pylori (Polyclonal) — BIO SB, INC.Beckmancoulter — IMMUNOTECHGt Anti-Human IgG (¿) HRPO Conjugate — LIFE TECHNOLOGIES CORPORATIONHuman CD105 R-PE Conjugate — LIFE TECHNOLOGIES CORPORATIONCMV — BIOCARE MEDICAL LLCCytoCell myProbes — CYTOCELL LIMITEDCytoCell myProbes — CYTOCELL LIMITEDAugurex — Augurex Life Sciences CorpCytoCell myProbes — CYTOCELL LIMITEDLambda-PE — CYTOGNOS SLVysis — ABBOTT MOLECULAR INC.CytoCell myProbes — CYTOCELL LIMITEDCytoCell myProbes — CYTOCELL LIMITEDEstrogen Receptor (RM292) — BIO SB, INC.SureFISH 10q11 RET 3' BA 623kb P20 GR5 — AGILENT TECHNOLOGIES, INC.PE anti-human Granzyme B — BIOLEGEND, INC.Human CD24 PE-Alexa Fluor® 610 Conj. — LIFE TECHNOLOGIES CORPORATIONProgesterone Receptor MMab — BIO SB, INC.COULTER CLONE MY4 — Beckman Coulter, Inc.CytoCell myProbes — CYTOCELL LIMITEDCytoCell — CYTOCELL LIMITEDCytoCell myProbes — CYTOCELL LIMITEDPD-1/CD279 RMab — BIO SB, INC.
Recent 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 |
| 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 resu |
| 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. | 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 |
| 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 chromos |
| 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. |
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