Maglumi 2000 HCG/beta-HCG
The MAGLUMI 2000 HCG/beta-HCG assay measures total beta human chorionic gonadotropin in human serum as an aid to early detection of pregnancy. It is a quantitative laboratory immunoassay…
The MAGLUMI 2000 HCG/beta-HCG assay measures total beta human chorionic gonadotropin in human serum as an aid to early detection of pregnancy. It is a quantitative laboratory immunoassay used with the MAGLUMI 2000 analyzer.
Antibody coated magnetic microbeads capture the hormone, and a labeled second antibody forms a sandwich complex. After magnetic separation and washing, starter reagents trigger a chemiluminescent reaction whose light signal is proportional to the hormone concentration.
Reagent and Calibration Components
The kit contains magnetic microbeads, buffer, labeled antibody reagent, low and high calibrators and two controls. Calibration uses two points. The assay is specified for serum samples, with a measuring range of 1.132 to 4680 mIU/mL.
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 | Shenzhen NEW Industries Biomedical Engineering Co., Ltd., China |
|---|---|
| FDA product code | DHA |
| Device type | System, Test, Human Chorionic Gonadotropin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Manufacturer |
| 510(k) | K192547 |
| Record published | 2024-05-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130202022M | In distribution | |
| 130602022M | 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 |
| 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
Showing 12 of 46. All products under System, Test, Human Chorionic Gonadotropin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192547 | 2020-01-17 |
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.