Kreatech Fish Probes
197 catalogue numbers from 21Q003I550, listed by Leica Biosystems Newcastle Ltd, United Kingdom, under Reagents, Specific, Analyte. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
197catalogue 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 | Leica Biosystems Newcastle Ltd, United Kingdom |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-19 |
| Record revised | 2026-01-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21Q003I550 | In distribution | |
| 17Q004V550 | In distribution | |
| 11Q009V495 | In distribution | |
| 16P001V495 | In distribution | |
| 23P003C495 | In distribution | |
| 16P002V550 | In distribution | |
| 07P001C495 | In distribution | |
| 11Q005I550 | In distribution | |
| 24C004J550 | In distribution | |
| KI-20017B | In distribution | |
| 16Q001I495 | In distribution | |
| 09Q004C415 | In distribution | |
| 40V000V495 | In distribution | |
| 12Q001V550 | In distribution | |
| 03Q008B495 | In distribution | |
| 22Q004V550 | In distribution | |
| KI-20008R | In distribution | |
| 40V006V495 | In distribution | |
| 10Q007V495 | In distribution | |
| 07Q004I550 | In distribution | |
| KI-20009R | In distribution | |
| 18Q004V550 | In distribution | |
| 13Q004I495 | In distribution | |
| 14Q001C415 | In distribution | |
| 20P001I495 | In distribution | |
| 12C001J495 | In distribution | |
| KI-40002 | In distribution | |
| 04C001B495 | In distribution | |
| 40V031V495 | In distribution | |
| 11Q001I495 | In distribution | |
| KI-20008B | In distribution | |
| 13Q001C550 | In distribution | |
| 10Q002B550 | In distribution | |
| 17P002V550 | In distribution | |
| 01P001B495 | In distribution | |
| 04C002C550 | In distribution | |
| 08Q006B550 | In distribution | |
| 04Q003C550 | In distribution | |
| 03Q002B495 | In distribution | |
| 06Q006V495 | In distribution | |
| 07Q002V550 | In distribution | |
| 13Q005V495 | In distribution | |
| 03Q007B550 | In distribution | |
| 06Q003B495 | In distribution | |
| 24C003J550 | In distribution | |
| 03Q006C415 | In distribution | |
| 05P001I495 | In distribution | |
| KI-20015B | In distribution | |
| 08P002B550 | In distribution | |
| 02P008V495 | In distribution | |
| 08Q001I550 | In distribution | |
| 03Q005C495 | In distribution | |
| 12C001C495 | In distribution | |
| 07Q001B550 | In distribution | |
| 23C001B495 | In distribution | |
| 17P001I550 | In distribution | |
| 04P001I495 | In distribution | |
| KI-20006R | In distribution | |
| KI-20007B | In distribution | |
| KI-20017G | In distribution | |
| 02P002B550 | In distribution | |
| 04Q004C415 | In distribution | |
| 09Q003B495 | In distribution | |
| KI-20018B | In distribution | |
| 40V033V495 | In distribution | |
| KI-20001G | In distribution | |
| 20Q002B495 | In distribution | |
| 03Q004B550 | In distribution | |
| KI-20010R | In distribution | |
| 21Q002B550 | In distribution | |
| 22Q001C495 | In distribution | |
| 07C003C415 | In distribution | |
| 10C003C415 | In distribution | |
| 12C002V495 | In distribution | |
| 14Q001I550 | In distribution | |
| 04P001B495 | In distribution | |
| 18C004J415 | In distribution | |
| 20Q003I550 | In distribution | |
| 09P004B550 | In distribution | |
| 06Q002B495 | In distribution | |
| 23P004C550 | In distribution | |
| 14Q001C495 | In distribution | |
| 03Q003B495 | In distribution | |
| 08P001B495 | In distribution | |
| 03Q004C550 | In distribution | |
| 17C003C495 | In distribution | |
| 13Q001I550 | In distribution | |
| 13Q006V550 | In distribution | |
| 05Q001B495 | In distribution | |
| 17Q002B550 | In distribution | |
| 23P001B550 | In distribution | |
| 02P005B495 | In distribution | |
| 13Q002C415 | In distribution | |
| KI-20006G | In distribution | |
| 20Q003B550 | In distribution | |
| 02P001B495 | In distribution | |
| 12P001B495 | In distribution | |
| 07Q004B550 | In distribution | |
| 14Q001B550 | In distribution | |
| KI-20001R | In distribution | |
| KI-20011G | In distribution | |
| 06Q003B550 | In distribution | |
| 15C001J495 | In distribution | |
| 09P005B550 | In distribution | |
| 02P006B550 | In distribution | |
| 08P004V550 | In distribution | |
| 09P003B495 | In distribution | |
| KI-20011B | In distribution | |
| 11Q003I495 | In distribution | |
| 40V018V495 | In distribution | |
| 10Q001B495 | In distribution | |
| 16Q003I550 | In distribution | |
| 18C001J415 | In distribution | |
| 11Q002I495 | In distribution | |
| 02P009V550 | In distribution | |
| 01Q005V550 | In distribution | |
| KI-20012R | In distribution | |
| 17C007V495 | In distribution | |
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| 16Q002I495 | In distribution | |
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| 08Q002I550 | In distribution | |
| 11Q008V550 | In distribution | |
| 06Q001A550 | In distribution | |
| 22Q002B550 | In distribution | |
| KI-20023B | In distribution | |
| 18Q002B550 | In distribution | |
| 22Q005V495 | In distribution | |
| 24C002N415 | In distribution | |
| 07C001B495 | In distribution | |
| KI-30004R | In distribution | |
| 03Q009V495 | In distribution | |
| 06Q005B550 | In distribution | |
| 40V016V495 | In distribution | |
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| 13Q003J550 | In distribution | |
| 08C002I495 | In distribution | |
| 10C001N495 | In distribution | |
| KI-30001R | In distribution | |
| 12Q002V550 | In distribution | |
| 14Q005V495 | In distribution | |
| 08C001B495 | In distribution | |
| 19P003B550 | In distribution | |
| 11Q001B495 | In distribution | |
| 07C003J415 | In distribution | |
| 16Q001B495 | In distribution | |
| 04Q001B550 | In distribution | |
| KI-40001 | In distribution | |
| 01Q001I550 | In distribution | |
| 40V000V000 | In distribution | |
| 17Q001I495 | In distribution | |
| 15C001C495 | In distribution | |
| 08P003B550 | In distribution | |
| 10Q008V550 | In distribution | |
| KI-20009G | In distribution | |
| 17P001B550 | In distribution | |
| 09Q005C550 | In distribution | |
| 08C003V495 | In distribution | |
| 23C004J495 | In distribution | |
| 01P001I495 | In distribution | |
| 23P002C550 | In distribution | |
| KI-20009B | In distribution | |
| 18Q003V495 | In distribution | |
| 09C001J550 | In distribution | |
| 04Q002C495 | In distribution | |
| 20P001B495 | In distribution | |
| 21Q001I495 | In distribution | |
| 17C006B495 | In distribution | |
| 18Q005V495 | In distribution | |
| 07P002V550 | In distribution | |
| 14Q004V550 | In distribution | |
| 08Q007V495 | In distribution | |
| KI-20012B | In distribution | |
| 13Q002C495 | In distribution | |
| 12Q003V495 | In distribution | |
| 01Q001B550 | In distribution | |
| 06Q007V550 | In distribution | |
| 04Q005B550 | In distribution | |
| 01P003B550 | In distribution | |
| 15Q001I550 | In distribution | |
| 18Q006V550 | In distribution | |
| 05Q004I550 | In distribution | |
| 23C002J495 | In distribution | |
| 07C006V495 | In distribution | |
| 03Q001B550 | In distribution | |
| 22Q003B495 | In distribution |
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 |
| Reagents, Specific, Analyte | Becton, Dickinson AND Company | 288 |
| Vysis | Abbott Molecular, Inc. | 248 |
| 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
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Kreatech Biotechnology Bv | UDI-DI | 2024-11-01 | Class II | Under Investigation by firm | 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 signal could also be observed as a result of the suboptimal hybridization of the | 23 units |
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.