Afias TSH-VB
AFIAS TSH-VB is a test for measuring thyroid-stimulating hormone in sodium-heparinised or EDTA venous whole blood. It is used with the AFIAS-6/VB analyser in clinical laboratories and…
AFIAS TSH-VB is a test for measuring thyroid-stimulating hormone in sodium-heparinised or EDTA venous whole blood. It is used with the AFIAS-6/VB analyser in clinical laboratories and point-of-care settings to monitor TSH levels in euthyroid and hypothyroid individuals.
The disposable test cartridge contains a lyophilised detection buffer, reconstitution buffer and test strip. The compatible analyser reads the immunofluorometric test to determine the TSH concentration in the sample.
Listed Item
AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals.
Lot Identification
A lot-specific electronic ID chip is an integral part of the test. Before testing a sample or control from a new cartridge lot, the operator inserts that lot’s TSH-VB chip into the AFIAS-6/VB analyser.
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Roche Diagnostics (Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Boditech MED Inc., South Korea |
|---|---|
| FDA product code | JLW |
| Device type | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1690 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K170232 |
| Record published | 2017-11-06 |
| Record revised | 2020-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AFIAS TSH-VB | 24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atellica IM TSH3-UL | Siemens Healthcare Diagnostics Inc | 4 |
| Elecsys TSH | Roche Diagnostics Gmbh | 4 |
| Advia Centaur® TSH3-UL | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® TSH | Siemens Healthcare Diagnostics Inc | 3 |
| Atellica IM TSH3-Ultra II | Siemens Healthcare Diagnostics Inc | 3 |
| Free T3, Free T4, TSH Thyroid Panel AccuBind Vast Elisa Test System – 960 Wells | Monobind, Inc. | 3 |
| Architect | Abbott Ireland | 2 |
| Immulite 2000 Third Generation TSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Thyrotropin (TSH) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| AccuDiag ™ | Diagnostic Automation, Inc. | 2 |
| Immulite® 2000 Systems TSH Third Generation TSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Maglumi 2000 TSH | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
Showing 12 of 87. All products under Radioimmunoassay, Thyroid-Stimulating Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170232 | 2017-10-13 |
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.