Pregcolor Plus
Catalogue number 89301, listed by Germaine Laboratories, Inc., United States, under System, Test, Human Chorionic Gonadotropin. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
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 | Germaine Laboratories, Inc., United States |
|---|---|
| FDA product code | DHA |
| Device type | System, Test, Human Chorionic Gonadotropin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2023-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89301 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013857 | 2002-01-22 |
| K974512 | 1998-01-02 |
| K974368 | 1998-01-02 |
| K973825 | 1997-12-19 |
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.