Rally #188-1-1880
Sekisui Diagnostics #1080
OSOM® Flu SARS-CoV-2 Combo Test (25/KT)
Rapid Test Combo (COVID-19, Flu A, & Flu B), Anterior Nasal Swab, Lateral Flow Immunochromatographic Assay, Rx Only
Sekisui Diagnostics 2025 Promotion
Test for COVID-19 and Flu at the same time!
Get 4 OSOM® Flu SARS-CoV-2 Combo Test kits for the price of 2
Offer Valid Through May 31, 2025 Only
See Details Below
- Rapid: Differentiate between three viral infections (COVID-19, Flu A, & Flu B) in only 10 minutes at the point-of-care.
- Reliable: Proven clinical performance to help you reduce the risk of misdiagnosis and inappropriate treatment.
- Cost Efficient: Unique QC Inside® feature that provides you with two additional tests for external quality control testing.
- Easy-to-Use: Ready-to-use extraction buffers contained in each sample collection tube, so you do not have to perform a rehydration or dispensing step.
- Peace-of-Mind: Manufactured in the USA so you can avoid delays from international product shipments.
Results are for the simultaneous in vitro detection and differentiation of SARSCoV-2, influenza A virus, and influenza B virus protein antigen, but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens. It is intended to aid in the rapid differential diagnosis of influenza A, influenza B, and COVID-19 viral infections.
All negative results are presumptive and do not rule out influenza or 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.
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 under an 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 including arsenic, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
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| Rally # | 188-1-1880 |
| Manufacturer # | 1080 |
| Brand | OSOM® |
| Manufacturer | Sekisui Diagnostics |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| Number of Tests | 25 Tests |
| Reading Type | Visual Read |
| Sample Type | Anterior Nasal Swab Sample |
| Test Format | Test Stick |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Immunochromatographic Assay |
| Test Name | Flu A + B / SARS-CoV-2 Combo |
| Time to Results | 10 Minute Results |
| UNSPSC Code | 41116144 |
| Storage Temperature | 15-30°C / 59-86°F |
| Type | Positive Percent Agreement* | Negative Percent Agreement* |
| SARS-CoV-2 | 87.0%** | 99.1% |
| Flu A | 93.1% | 99.5% |
| Flu B | 89.1% | 99.7% |
* Combined prospective clinical RT-PCR comparator study.
** Determined by a controlled analysis: Data shown is inclusion of 10% low positive samples by PCR. For all study cohort and performance at different low positive samples levels refer to IFU.
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Configurations
Configurations
| Product ID | Description | Quantity |
| 1080 | OSOM FLU SARS-CoV-2 Combo Test | 25 Tests Per Kit |
| 1079 | OSOM FLU SARS-CoV-2 Combo Control Kit | 5 x Flu A/Flu B/SARS-CoV-2 Positive Control Swabs 5 x Flu A/Flu B/SARS-CoV-2 Negative Control Swabs |
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Kit Content
- 25 - Sterile Nasal Swabs
- 27* - Test Sticks
- 27* - Extraction Buffer vials each containing 0.25 mL phosphate buffered salt solution (with 0.09% sodium azide as a preservative)
- 1 - Flu A / Flu B / SARS-CoV-2 Positive Control Swab (packaged with a desiccant tablet) coated with non-infectious recombinant influenza A, influenza B, and SARS-CoV-2 containing 0.05% sodium azide
- 1 - Flu A / Flu B / SARS-CoV-2 Negative Control Swab (packaged with a desiccant tablet) coated with nonviable Group C Streptococci containing 0.09% sodium azide
- 2 - Result Interpretation Cards
- 1 - Instructions for Use (IFU)
- 1 - Quick Reference Guide (QRG)
- 1 - Workstation
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Documentation Links
Documentation Links
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Promotional Information
Test for COVID-19 and Flu at the same time!
Get 4 OSOM® Flu SARS-CoV-2 Combo Test kits for the price of 2
Offer Valid Through May 31, 2025 Only
Requirements:
The customer will receive a Proof of Purchase from Rally Inc. after purchasing the product. However, the promotional offer is handled solely between you, the customer, and the manufacturer, Sekisui Diagnostics. Rally Inc. does not oversee these offers. To check eligibility for the promotion and receive your promotional item, please follow the manufacturer's online instructions.
You can find more informations on the promotion and their required form here.
Promotional Information
Sekisui Diagnostics 2025 Promotion
Test for COVID-19 and Flu at the same time!
Get 4 OSOM® Flu SARS-CoV-2 Combo Test kits for the price of 2
Offer Valid Through May 31, 2025 Only
Requirements:
- Proof of purchase of 2 OSOM® Flu SARS-CoV-2 Combo Test Kits (cat. no. 1080) on one invoice required.
- All redemptions must be received by the listed date on the flyer.
- Offer limited to 6 no charge kits per customer.
The customer will receive a Proof of Purchase from Rally Inc. after purchasing the product. However, the promotional offer is handled solely between you, the customer, and the manufacturer, Sekisui Diagnostics. Rally Inc. does not oversee these offers. To check eligibility for the promotion and receive your promotional item, please follow the manufacturer's online instructions.
You can find more informations on the promotion and their required form here.
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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 laws 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 reimbursement instructions.You can find more informations on reimbursement details here.
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Please see the Package Insert of this product for complete EUA information.
EUA - Emergency Use Authorization
In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.Please see the Package Insert of this product for complete EUA information.
