Alinity
Alinity i Total B-hCG Reagent Kit 1200 Tests
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Abbott Ireland, Ireland |
|---|---|
| FDA product code | DHA |
| Device type | System, Test, Human Chorionic Gonadotropin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2018-05-31 |
| Record revised | 2023-10-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07P5121 | In distribution | |
| 07P5131 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSign® hCG card | Princeton BioMeditech Corp. | 5 |
| Architect | Abbott Ireland | 5 |
| BioStrip® P | Princeton BioMeditech Corp. | 4 |
| AccuHome Pregnancy Test | Germaine Laboratories, Inc. | 3 |
| Elecsys HCG Test System | Roche Diagnostics Gmbh | 3 |
| Status hCG card | Princeton BioMeditech Corp. | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Maglumi 2000 HCG/beta-HCG | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Access Total BhCG (5th IS) | Beckman Coulter, Inc. | 2 |
| Immulite®/Immulite® 1000 Systems HCG Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Immulite® 2000 Systems HCG | Siemens Healthcare Diagnostics Products GmbH | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
Showing 12 of 46. All products under System, Test, Human Chorionic Gonadotropin
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.