Anti-Streptolysin-O 2 (ASO 2)
4 catalogue numbers from LO8305, listed by Randox Laboratories Limited, United Kingdom, under Antistreptolysin - Titer/Streptolysin O Reagent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LO8305 | In distribution | |
| LO3999 | In distribution | |
| LO3998 | In distribution | |
| LO8015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 8 |
| 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 |
| Immage | Beckman Coulter, 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.