Reagents, Specific, Analyte
BD® Anti-Human Myeloperoxidase (5B8) FITC
6manufacturers in China registered for this device type
288catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Shenzhen Dartmon Biotechnology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai ZJ BIO-Tech Co., Ltd. | Shanghai | Shanghai | Private-label distributor | 3 |
| Diaglogic Biolabs (Xiamen) Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-11-28 |
| Record revised | 2025-08-13 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2019-01-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 655933 | In distribution | |
| 333948 | In distribution | |
| 666645 | In distribution | |
| 340713 | In distribution | |
| 656159 | In distribution | |
| 340682 | In distribution | |
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| 340950 | In distribution | |
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| 666644 | In distribution | |
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| 340850 | In distribution | |
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| 335805 | In distribution | |
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| 340765 | In distribution |
Showing 250 of 288 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CytoCell myProbes | Cytocell Limited | 1,286 |
| Beckmancoulter | Immunotech Corp. | 678 |
| CytoCell | Cytocell Limited | 587 |
| MetaSystems Probes | Metasystems Probes Gmbh | 529 |
| Vysis | Abbott Molecular, Inc. | 248 |
| Kreatech Fish probes | Leica Biosystems Newcastle Ltd | 197 |
| Horizon | Becton, Dickinson AND Company | 145 |
| goldFISH | Lumatas Biosystems, Inc | 119 |
| Immunalysis | Immunalysis Corporation | 97 |
| Invivoscribe | Invivoscribe, Inc. | 91 |
| Fort Worth Diagnostics | Fort Worth Diagnostics LLC | 88 |
| Novocastra™ | Leica Biosystems Newcastle Ltd | 29 |
Showing 12 of 3,073. All products under Reagents, Specific, Analyte
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson and Company, BD Biosciences | UDI-DI | 2023-10-25 | Class II | Nonconforming Material/Component | 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 of hematological malignancy, delayed treatment, and the nee | 464 Vials | |
| Becton, Dickinson and Company, BD Biosciences | UDI-DI | 2022-03-25 | Class II | Process control | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | 249 units | |
| Becton, Dickinson and Company, BD Biosciences | UDI-DI | 2022-03-25 | Class II | Process control | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | 199 units | |
| Becton, Dickinson and Company, BD Biosciences | UDI-DI | 2021-07-22 | Class II | Nonconforming Material/Component | Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another an | 23 reagents | 2023-03-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.