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Antistreptolysin - Titer/Streptolysin O Reagent
FDA product code GTQ · Class 1 · Microbiology
53
Registered devices
6
Adverse events
4
Recalls
37
510(k) clearances
Devices with this code
Dimension Vista®Antistreptolysin O Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHTeco Diagnostics Anti-Streptolysin O (ASO) Reagent Set — TECO DIAGNOSTICSARCHITECT — ABBOTT LABORATORIESWampole ColorCard® ASO — ALERE NORTH AMERICA, LLCANTI-STREPTOLYSIN-O 2 (ASO 2) — RANDOX LABORATORIES LIMITEDANTI-STREPTOLYSIN-O 2 (ASO 2) — RANDOX LABORATORIES LIMITEDAtellica CH Anti-Streptolysin-O_3 (ASO_3) — Siemens Healthcare Diagnostics Inc.N Latex ASL — Siemens Healthcare Diagnostics Products GmbHRapiTex® ASL — Siemens Healthcare Diagnostics Products GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Tina-quant Antistreptolysin O — Roche Diagnostics GmbHInstaTest™ — Diagnostic Automation, Inc.N Latex ASL — Siemens Healthcare Diagnostics Products GmbHRaPET® ASO — STANBIO LABORATORY, L.P.ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents — Siemens Healthcare Diagnostics Inc.Human Anti Streptolysin-O kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDRheumajet ASO 100 TESTS — BIOKIT, S.A.K-ASSAY® ASO (WHO) Reagent — KAMIYA BIOMEDICAL COMPANY, LLCAntistreptolysin O — Roche Diagnostics GmbHAlinity — ABBOTT LABORATORIESRapiTex® ASL — Siemens Healthcare Diagnostics Products GmbHTeco Diagnostics Anti-Streptolysin O (ASO) Reagent Set — TECO DIAGNOSTICSTina-quant Antistreptolysin-O II — Roche Diagnostics GmbHABX PENTRA ASO CP — HORIBA ABX SAS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-11-18 | Remel, Inc | These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus. |
| 2007-08-08 | BD Diagnostic Systems / Lee Laboratories | Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism. |
| 2006-07-25 | Roche Diagnostics Corp. | 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 pat |
| 2003-12-17 | Beckman Coulter Inc | The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5. |
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