Vitros
VITROS Chemistry Products ASO/RF Performance Verifier II
3manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | GTQ |
| Device type | Antistreptolysin – Titer/Streptolysin O Reagent |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-18 |
| Record revised | 2023-06-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Packaging | Case of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6802411 | In distribution | |
| 6802218 | In distribution | |
| 6802412 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 8 |
| Anti-Streptolysin-O 2 (ASO 2) | Randox Laboratories Limited | 4 |
| Architect | Abbott Laboratories | 4 |
| RapiTex® ASL | Siemens Healthcare Diagnostics Products GmbH | 3 |
| Tina-quant Antistreptolysin O | Roche Diagnostics Gmbh | 3 |
| N Latex ASL | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set | Teco Diagnostics | 2 |
| RaPET® ASO | Stanbio Laboratory, L.P. | 2 |
| Tina-quant Antistreptolysin-O II | Roche Diagnostics Gmbh | 2 |
| Optilite Anti-Streptolysin-O Kit | The Binding Site Group Ltd. | 1 |
| AIM ASO Test | Germaine Laboratories, Inc. | 1 |
| Immage | Beckman Coulter, Inc. | 1 |
Showing 12 of 29. All products under Antistreptolysin – Titer/Streptolysin O Reagent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K052645 | 2005-12-14 |
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.