Rally #188-1-1091
Sekisui Diagnostics #1091
OSOM® RSV Test (25/BX)
Rapid Test, RSV, Anterior Nasal Swab, Immunochromatographic Assay, CLIA Complexity Waived, External Controls Included
Features
- Fast & Reliable: Results in 15 minutes.
- Flexible Use: Designed for both young children and older adults.
- Easy to Use: Simple procedure with ready-to-use buffer tubes.
- Noninvasive: Uses comfortable anterior nasal swabs.
- Cost-Efficient: Includes two extra tests per kit for quality control (QC Inside®).
Important Notes:
- Restricted Product: Rx Only - Current Valid Medical License Required.
- This product is Non-Returnable. Please verify your ordering information before making a purchase.
- For In Vitro Diagnostic Use
- For Use with Kit Provided Swabs
- CLIA waived for use with anterior nasal swabs.
- Certificate of Waiver is required to perform the test in a waived setting.
- Do not freeze and bring to room temperature at least 30 minutes prior to use.
- Once opened, the test device should be used within 90 minutes.
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
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| Rally # | 188-1-1091 |
| Manufacturer # | 1091 |
| Brand | OSOM® |
| Manufacturer | Sekisui Diagnostics |
| Country of Origin | Unknown |
| Application | Respiratory Test Kit |
| CLIA Complexity | Waived |
| Number of Tests | 25 Tests + 2 Extra Tests For Quality Control |
| Reading Type | Visual Read |
| Sample Type | Anterior Nasal Swab Sample |
| Test Kit Type | Rapid |
| Test Method | Immunochromatographic Assay |
| Test Name | Respiratory Syncytial Virus (RSV) |
| Time to Results | 15 Minute Results |
| Sensitivity | 83.8% |
| Specificity | 99.6% |
| Limit of Detection | 1.6 x 103 TCID50 / mL |
| Storage Temperature | 2-30°C/ 36-86°F |
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Configurations
Currently Unavailable
Configurations
Currently Unavailable
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Package Contents
Package Contents
- 27* - Test devices in sealed aluminum foil pouch with desiccant
- 27* - Reagent tubes prefilled with extraction buffer (350 µL) and dropper tips
- 25 - Sample collection swabs (Anterior Nasal)
- 1 - Positive control swab (noninfectious RSV antigen)
- 1 - Negative control swab (noninfectious nasal clinical matrix)
- 1 - Instructions for Use (IFU)
- 1 - Quick Reference Guide (QRG)
*Note: Two extra test devices have been included for external QC testing.
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Reimbursements Information
This product may be eligible for reimbursement depending on current laws, policies, and individual circumstances. Please note that Rally Inc. does not handle, manage or process any reimbursements. All reimbursement matters are handled directly between you and the product manufacturer. To determine your eligibility and request reimbursement, please follow the manufacturer's reimbursement guidelines and instructions.
You can find more information on reimbursement details for this product below:
CPT Code: 87807QW
Link: OSOM RSV Sales Sheet.
Disclaimer:
Rally Inc. assumes no responsibility for the accuracy, completeness, or timeliness of the reimbursement information provided by the product manufacturer. Reimbursement policies are subject to change, and customers are encouraged to contact the product manufacturer directly for the most current information.
Reimbursements Information
This product may be eligible for reimbursement depending on current laws, policies, and individual circumstances. Please note that Rally Inc. does not handle, manage or process any reimbursements. All reimbursement matters are handled directly between you and the product manufacturer. To determine your eligibility and request reimbursement, please follow the manufacturer's reimbursement guidelines and instructions.
You can find more information on reimbursement details for this product below:
CPT Code: 87807QW
Link: OSOM RSV Sales Sheet.
Disclaimer:
Rally Inc. assumes no responsibility for the accuracy, completeness, or timeliness of the reimbursement information provided by the product manufacturer. Reimbursement policies are subject to change, and customers are encouraged to contact the product manufacturer directly for the most current information.
