P504s (13h4) Rabbit Monoclonal Antibody
2 catalogue numbers from 504R-17-ASR, listed by Cell Marque Corp., United States, under Reagents, Specific, Analyte. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
7recalls on this code
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 | Cell Marque Corp., United States |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-15 |
| Record revised | 2021-11-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2021-11-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 504R-17-ASR | Withdrawn | |
| 504R-18-ASR | Withdrawn |
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
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-05-27 | Class II | Process control | Product distributed for use as an In-vitro Diagnostics without FDA clearance | 41 kits | 2024-04-05 |
| 2021-05-27 | Class II | Process control | Product distributed for use as an In-vitro Diagnostics without FDA clearance | 2 units | 2024-04-05 |
| 2017-05-05 | Class II | Labeling mix-ups | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as “For Export Only” as required by section 801 (e )(1) of the FD&C Act. | 8 | 2017-09-07 |
| 2017-05-05 | Class II | Labeling mix-ups | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as “For Export Only” as required by section 801 (e )(1) of the FD&C Act. | 3 | 2017-09-07 |
| 2017-05-05 | Class II | Labeling mix-ups | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as “For Export Only” as required by section 801 (e )(1) of the FD&C Act. | 12 | 2017-09-07 |
| 2017-05-05 | Class II | Labeling mix-ups | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as “For Export Only” as required by section 801 (e )(1) of the FD&C Act. | 2017-09-07 | |
| 2017-05-05 | Class II | Labeling mix-ups | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as “For Export Only” as required by section 801 (e )(1) of the FD&C Act. | 11 | 2017-09-07 |
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.