Fort Worth Diagnostics
Asuragen Internal Process Control Primer Set
6manufacturers in China registered for this device type
88catalogue 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 | Fort Worth Diagnostics LLC, United States |
|---|---|
| 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 | 2024-03-01 |
| Record revised | 2026-07-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Storage | Storage environment temperature up to -20 °C |
| Distribution end date | 2026-07-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GBS001 | In distribution | |
| CSPP002 | In distribution | |
| CPOS002 | In distribution | |
| BAT001 | In distribution | |
| MEAS002 | In distribution | |
| LPNE001 | In distribution | |
| LSPP003 | In distribution | |
| PEV004 | In distribution | |
| HHV6B002 | In distribution | |
| JCV002 | In distribution | |
| EHR002 | In distribution | |
| UREA002 | In distribution | |
| MIY003 | In distribution | |
| FLUB001 | In distribution | |
| HPV52002 | In distribution | |
| MIY004 | In distribution | |
| FLUA003 | In distribution | |
| BAB004 | In distribution | |
| RSV001 | In distribution | |
| H5N1003 | In distribution | |
| VZV002 | In distribution | |
| ATO002 | In distribution | |
| COCC002 | In distribution | |
| KRU002 | In distribution | |
| HSV2004 | In distribution | |
| ANA001 | In distribution | |
| ANA002 | In distribution | |
| BOR002 | In distribution | |
| HPV31002 | In distribution | |
| HSV1004 | In distribution | |
| ADV003 | In distribution | |
| LSPP001 | In distribution | |
| MIY001 | In distribution | |
| PEV002 | In distribution | |
| HPV33002 | In distribution | |
| H5N1005 | In distribution | |
| ADV002 | In distribution | |
| H5N1001 | In distribution | |
| FLUA005 | In distribution | |
| ANA003 | In distribution | |
| BAB003 | In distribution | |
| JCV001 | In distribution | |
| H5N1002 | In distribution | |
| CAUR002 | In distribution | |
| HHV6A002 | In distribution | |
| VZV004 | In distribution | |
| BMI002 | In distribution | |
| HHV6002 | In distribution | |
| ANA006 | In distribution | |
| MYCO002 | In distribution | |
| CIMM002 | In distribution | |
| BAB002 | In distribution | |
| PJP003 | In distribution | |
| PJP002 | In distribution | |
| ASU001 | In distribution | |
| MEGA002 | In distribution | |
| VZV003 | In distribution | |
| LPNE003 | In distribution | |
| PJP001 | In distribution | |
| MIY002 | In distribution | |
| MIY006 | In distribution | |
| GLA002 | In distribution | |
| LSPP002 | In distribution | |
| MEAS001 | In distribution | |
| GAR002 | In distribution | |
| EV002 | In distribution | |
| BAB001 | In distribution | |
| CAUR001 | In distribution | |
| COV001 | In distribution | |
| HPV45002 | In distribution | |
| EHR001 | In distribution | |
| HSV1002 | In distribution | |
| HSV2002 | In distribution | |
| BGLO001 | In distribution | |
| EV004 | In distribution | |
| BVAB002 | In distribution | |
| FLUA001 | In distribution | |
| LPNE002 | In distribution | |
| BGLO002 | In distribution | |
| EHR001 | Withdrawn | |
| ADV002 | Withdrawn | |
| MIY001 | Withdrawn | |
| RSV001 | Withdrawn | |
| BAB002 | Withdrawn | |
| ANA001 | Withdrawn | |
| ANA002 | Withdrawn | |
| BOR001 | Withdrawn | |
| BAB001 | 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 |
| Novocastra™ | Leica Biosystems Newcastle Ltd | 29 |
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.