Rally #188-1-6640
Sekisui Diagnostics #1066-40
OSOM® COVID-19 Antigen Rapid Test (40/KT)
Antigen Rapid Test, COVID-19, Mid-Turbinate Swab, Lateral Flow Chromatographic Immunoassay, Rx Only
Features
- High positive percent agreement & negative percent agreement to help you reduce the risk of misdiagnosis & inappropriate treatment
- Can be performed in a CLIA-waived setting & comes with everything you need to run a test, without the need for specialized equipment
- Get results to your patient in only 15 minutes
- Direct Mid-Turbinate nasal swab to help you improve patient comfort
- Proudly made in the USA & backed by a trustworthy supply chain so you can avoid delays from international shipments
All negative results are presumptive and do not rule out SARS-CoV-2 infection. Negative results should not be used as the sole basis for treatment or patient management decisions.
This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The OSOM COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARSCoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in MT nasal swab specimens during the acute phase of infection.
The OSOM COVID-19 Antigen Rapid Test is intended for use by healthcare professionals or operators who are proficient in performing tests in point of care settings.
Important Notes
- Product is non-returnable; please make sure it is the right product before ordering.
- Testing must be performed within 30 minutes of specimen collection.
- For In Vitro Diagnostic Use
- For Directly Collected Mid-turbinate Nasal Swab Specimens
- For Use Under Emergency Use Authorization (EUA) Only
- For more information on this product's EUA, please go to the EUA section below.
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 # | 188-1-6640 |
| Manufacturer # | 1066-40 |
| Brand | OSOM® |
| Manufacturer | Sekisui Diagnostics |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| Number of Tests | 40 Tests |
| Reading Type | Visual Read |
| Sample Type | Direct Mid-Turbinate Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Test Device Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Chromatographic Immunassay |
| Test Name | Covid-19 Antigen |
| Time to Results | 15 Minute Results |
| UNSPSC Code | 41116144 |
| Storage Temperature | 15-30 °C / 59-86 °F |
| Positive Percent Agreement* | 95.1% |
| Negative Percent Agreement* | 97.0% |
*Compared to RT-PCR. See IFU.
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Configurations
Configurations
| Product ID | Description | Quantity |
| 1066-40 | OSOM® COVID-19 Antigen Rapid Test | 40 Tests Per Kit |
| 1068 | OSOM® COVID-19 Antigen Control Kit | 5 x SARS-CoV-2 Positive Control Swabs 5 x SARS-CoV2 Negative Control Swabs |
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Materials Provided in Each Test Kit
Materials Provided in Each Test Kit
| Material | Description | Quantity |
| OSOM COVID-19 Antigen Test Devices | Test devices containing LFI test strip in a plastic housing | 40 |
| OSOM Antigen Buffer Tubes | Nasal swab specimen collection & dispensing tube containing OSOM Antigen Buffer | 2 x 20 |
| Sterile, Nasal Swabs | Mid-Turbinate Nasal Swab | 40 |
| Instructions For Use (IFU) | 1 | |
| Quick Reference Guide | For Direct Nasal Swab Samples | 1 |
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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.
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