Rally #188-1-1032
Sekisui Diagnostics #1032
OSOM® Ultra Plus Flu A&B Test (25/BX)
Rapid Test, Flu A & B, Nasal/NP Swab, Immunochromatographic Assay, CLIA Complexity Waived, Rx Only
Features
- Accurate – High Sensitivity / Specificity
- CLIA-waived – No need for instrument
- Fast and simple workflow – Pre-filled Vials, Minimal hands on time, Results in 10 minutes
- Ready-to-use – Collection Swabs and Controls Included
- QC Inside®: 2 Additional test sticks for external QC
It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza C viruses. A negative test result is presumptive, and it is recommended these results be confirmed by viral culture or an FDAcleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Important Note:
- Product is non-returnable; please make sure it is the right product before ordering.
- If put into refrigeration, do not freeze.
- For in vitro diagnostic use.
- For use with nasal and nasopharyngeal swab specimens.
- New product shipment
- Change in lot number
- New untrained user
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 # | 188-1-1032 |
| Manufacturer # | 1032 |
| Brand | OSOM® Ultra Plus |
| Manufacturer | Sekisui Diagnostics |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Complexity | Waived |
| Number of Tests | 25 Tests |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab / Nasopharyngeal Swab Sample |
| Test Method | Immunochromatographic Assay |
| Test Format | Dipstick Format |
| Test Kit Type | Rapid |
| Test Name | Influenza A + B |
| Time to Results | 10 Minute Results |
| UNSPSC Code | 41116144 |
| Storage Temperature | 15-30°C / 59-86°F |
| Type | Sensitivity* | Specificity* |
| FLU A | 90.3% | 96.7% |
| FLU B | 88.0% | 99.2% |
* When compared with RT-PCR
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Configurations
Configurations
| Product ID | Description | Quantity |
| 1032 | OSOM Ultra Plus FLU A&B Test Kit | 25 Tests Per Kit |
| 1034 | OSOM Ultra Plus FLU A&B Control Kit | 5 Flu A Swabs, 5 Flu B Swabs |
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Kit Contents
- 25 - Test Sticks
- 25 - Sterile Nasal Swabs
- 25 - Extraction Buffer vials each containing 0.25 mL phosphate buffered salt solution (with 0.09% sodium azide as a preservative)
- 1 - Influenza A+ Control Swab (packaged with a desiccant tablet) coated with non-infectious recombinant influenza A containing 0.05% sodium azide
- 1 - Influenza B+ Control Swab (packaged with a desiccant tablet) coated with non-infectious recombinant influenza B containing 0.05% sodium azide
- 1 - Instructions for Use (IFU)
- 1 - Quick Reference Guide (QRG)
- 1 - Workstation
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Documentation Links
Documentation Links
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Promotions are currently not available at this time. Please check back later.
Promotions are currently not available at this time. Please check back later.
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You can find more informations on reimbursement details here.
- Reimbursements Information -
This product maybe reimbursable, depending on various factors including current law and policies. Rally Inc. does not handle these reimbursements; instead, each reimbursement is handled solely between you, the customer, and the manufacturer, SEKISUI Diagnostics LLC. Rally Inc. does not oversee these reimbursements. To check eligibility and get your reimbursements, please follow the manufacturer's reimbursements instructions.You can find more informations on reimbursement details here.
