Tina-Quant Antistreptolysin-O II
2 catalogue numbers from 09537368190, listed by Roche Diagnostics Gmbh, Germany, under Antistreptolysin - Titer/Streptolysin O Reagent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-05-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09537368190 | In distribution | |
| 09537341190 | 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 |
| 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-07-25 | Not classified | Other | The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results) | 20 kits. | 2007-04-18 |
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.