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Reagents, Specific, Analyte
FDA product code MVU · Class 1 · Pathology
8,318
Registered devices
74
Adverse events
43
Recalls
0
510(k) clearances
Devices with this code
Tinto Estrogen Receptor (EP1) — BIO SB, INC.CytoCell myProbes — CYTOCELL LIMITEDN/A — Becton, Dickinson And CompanyHorizon — Becton, Dickinson And CompanyAnti-SV40 T Ag — BIOGENEX LABORATORIESMetaSystems Probes — MetaSystems Probes GmbHMetaSystems Probes — MetaSystems Probes GmbHCytoCell — CYTOCELL LIMITEDSureFISH 12q14.1 DDIT3 5'BA 498kb P5 GR6 — AGILENT TECHNOLOGIES, INC.SureFISH 2p14 MEIS1 3' BA 300kb P20 RD — AGILENT TECHNOLOGIES, INC.MGB Alert® hMPV Probe Mix ASR - 48 Reactions — Elitechgroup Mdx LLCBeckmancoulter — IMMUNOTECHProgesterone Receptor (EP2) — BIO SB, INC.MGB PROBE 100 NMOL VIC — LIFE TECHNOLOGIES CORPORATIONSureFISH ROS1-GOPC 3' BA 1132kb P100 GR — AGILENT TECHNOLOGIES, INC.Horizon — Becton, Dickinson And CompanyFort Worth Diagnostics — Fort Worth Diagnostics, LLCProgesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATIONBeckmancoulter — IMMUNOTECHTinto HER-2 neu, RMab — BIO SB, INC.Pacific Blue™ anti-human CD38 — BIOLEGEND, INC.Helicobacter pylori [EPR10353] — BIOCARE MEDICAL LLCCOULTER CLONE NKH-1 — Beckman Coulter, Inc.Kreatech FISH probes — LEICA BIOSYSTEMS NEWCASTLE LTD
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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