Dimension Human Chorionic Gonadotropin Flex Reagent Cartridge
Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
5recalls on this 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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K970387 |
| Record published | 2016-09-24 |
| Record revised | 2023-07-06 (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 | Per pack | Status |
|---|---|---|---|
| 10444914 | 4 | 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 |
|---|---|
| K200210 | 2021-07-13 |
| K192790 | 2019-10-30 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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) | |
| 2015-11-11 | Class II | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 590 | 2016-09-23 |
| 2015-11-11 | Class II | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 196 | 2016-09-23 |
| 2006-04-03 | Not classified | Other | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magn | 1151 cartons of 5 DilPaks | 2006-08-07 |
| 2006-04-03 | Not classified | Other | Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magn | 126 cartons of 100 TestPaks | 2006-08-07 |
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.