Immulite® 2000 Systems HCG Sample Diluent
HCG Sample Diluent - IMMULITE - 1x50mL
3manufacturers in China registered for this device type
1catalogue number
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 | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | DHA |
| Device type | System, Test, Human Chorionic Gonadotropin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K990222 |
| Record published | 2016-09-24 |
| Record revised | 2023-06-02 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10387051 | 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 |
| Alinity | Abbott Ireland | 2 |
| Immulite® 2000 Systems HCG | Siemens Healthcare Diagnostics Products GmbH | 2 |
Showing 12 of 46. All products under System, Test, Human Chorionic Gonadotropin
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2022-02-22 | Class II | Under Investigation by firm | Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. | 10,755 boxes (533 US, 10,222 OUS) |
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.