Wampole ColorCard® ASO
Catalogue number 47050, listed by Alere North America, LLC, under Antistreptolysin - Titer/Streptolysin O Reagent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 | Alere North America, LLC |
|---|---|
| FDA product code | GTQ |
| Device type | Antistreptolysin – Titer/Streptolysin O Reagent |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3720 |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47050 | 50 | 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 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 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 |
Showing 12 of 29. All products under Antistreptolysin – Titer/Streptolysin O Reagent
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.