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Antistreptolysin - Titer/Streptolysin O Reagent
FDA product code GTQ · Class 1 · Microbiology
50
Registered devices
5
Adverse events
4
Recalls
37
510(k) clearances
Devices with this code
Dimension Vista®Antistreptolysin O Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHRheumajet ASO 100 TESTS — BIOKIT, S.A.ASO Titer Control — BIOKIT, S.A.ARCHITECT — ABBOTT LABORATORIESTeco Diagnostics Anti-Streptolysin O (ASO) Reagent Set — TECO DIAGNOSTICSN Latex ASL — Siemens Healthcare Diagnostics Products GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Anti-Streptolysin O (ASO) — RANDOX LABORATORIES LIMITEDAtellica CH ASO_2 — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.K-ASSAY® ASO (WHO) Reagent — KAMIYA BIOMEDICAL COMPANY, LLCVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.ANTI-STREPTOLYSIN-O 2 (ASO 2) — RANDOX LABORATORIES LIMITEDRaPET® ASO — STANBIO LABORATORY, L.P.Optilite Anti-Streptolysin-O Kit — THE BINDING SITE GROUP LIMITEDK-ASSAY® ASO (WHO) Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCTina-quant Antistreptolysin O — Roche Diagnostics GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESANTI-STREPTOLYSIN-O 2 (ASO 2) — RANDOX LABORATORIES LIMITEDRapiTex® ASL — Siemens Healthcare Diagnostics Products GmbHAtellica CH Anti-Streptolysin-O_3 (ASO_3) — Siemens Healthcare Diagnostics Inc.
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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