Novocastra™
NCL-L-Hpylori is intended for the qualitative identification by light microscopy of Helicobacter pylori in paraffin sections.
6manufacturers in China registered for this device type
29catalogue 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 | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IHC5994-A | In distribution | |
| ISH5950-A | In distribution | |
| DYS3-A | In distribution | |
| PSMA-L-A | In distribution | |
| ISH5748-A | In distribution | |
| HPYLORI-L-CE | In distribution | |
| ISH5719-A | In distribution | |
| G-SARC-A | In distribution | |
| HAMLET-2-A | In distribution | |
| B-DG-A | In distribution | |
| EMERIN-A | In distribution | |
| ISH5770-A | In distribution | |
| D-SARC-A | In distribution | |
| HAMLET-A | In distribution | |
| MEROSIN-A | In distribution | |
| ISH5687-A | In distribution | |
| BOB-1-L-A | In distribution | |
| SPEC1-A | In distribution | |
| DYS1-A | In distribution | |
| DRP2-A | In distribution | |
| DYS2-A | In distribution | |
| HPYLORI-L-A | In distribution | |
| AK2-L-A | In distribution | |
| A-SARC-L-A | In distribution | |
| CK8-TS1-L-A | In distribution | |
| VILLIN-L-A | In distribution | |
| VEGFR3-L-A | In distribution | |
| ISH5894-A | In distribution | |
| B-SARC-L-A | 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 |
| 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 |
Showing 12 of 3,073. All products under Reagents, Specific, Analyte
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.