Rally #188-1-1915
Sekisui Diagnostics #MTRX‑C19+FLU‑25PK
The Metrix® COVID/Flu Test (25/KT)
Respiratory Test Kit, Molecular NAAT (RT‑LAMP), Covid-19/FLU A+B, Anterior Nasal Swab, Machine-Read.
Features
- Detects SARS-CoV-2, Influenza A, and Influenza B in one test using a single nasal swab.
- Provides fast, high-accuracy results in approximately 20 minutes.
- Uses anterior nasal swabs for simple and minimally invasive sample collection.
- Includes 25 complete test kits with swabs, collectors, buffer caps, and reaction sensors.
- Designed for use in clinics, urgent care centers, and other point-of-care settings.
- Requires no maintenance or calibration, making it ready for testing at any time.
Important Note:
- For in vitro diagnostic use.
- Non-Returnable: Due to safety regulations, returns are not accepted for this item.
- For use with the Metrix Reader (Gen 2) Only.
- All components other than the Metrix Reader (Gen 2) are single use and should be disposed of after use.
- Authorized for Use in Patient Care Settings with a CLIA Certificate of Waiver Under FDA EUA.
- For use under Emergency Use Authorization (EUA) only.
- For more information on this product's EUA, please go to the EUA section below.
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| Rally # | 188-1-1915 |
| Manufacturer # | MTRX‑C19+FLU‑25PK |
| Brand | Metrix® |
| Manufacturer | Sekisui Diagnostics |
| Country of Origin | Unknown |
| Application | Respiratory Multiplex Test (COVID‑19, Influenza A & B) |
| For Use With | Metrix® Reader (Gen 2) |
| Number of Tests | 25 Tests/Kit |
| Reading Type | Machine‑read via Metrix Reader |
| Sample Type | Anterior nasal swab (self or adult-collected) |
| Test Format | Single-use sensor device |
| Technology | RT-LAMP (isothermal nucleic acid amplification) |
| Multiplex Capability | Detects SARS‑CoV‑2, Flu A, Flu B |
| Time to Results | 20 minutes |
| Storage Conditions | Room Temperature, 15–30 °C (59–86 °F) |
| Usage | Single Use Only |
| Analyte | Positive Percent Agreement (PPA) | Negative Percent Agreement (NPA) | Limit of Detection (LOD) |
| SARS-CoV-2 | 96% | 99% | 500 GE/Swab |
| Flu A | 96% | 99% | 1000 GE/Swab |
| Flu B | 95% | 99% | 2000 GE/Swab |
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Configurations
Configurations
| Description | Quantity | Catalog Number |
| Metrix Reader (Gen 2) | 1 Reader | MTRX-RDR-Gen2 |
| Metrix COVID/Flu Test | 25 Tests | MTRX-C19+Flu-25PK |
| Metrix COVID/Flu Molecular Test Bundle | 1 Reader + 50 Tests | MTRX-C19+FLU-B1 |
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Package Contents
This 25 pack contains: Instructions and 25 collectors, 25 caps, 25 sensors, and 25 nasal swabs.
Package Contents
This 25 pack contains: Instructions and 25 collectors, 25 caps, 25 sensors, and 25 nasal swabs.
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Emergency Use Authorization
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;
This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and,
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.
Additional information about this product’s authorization can be found on the FDA Website.
Emergency Use Authorization
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;
This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and,
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.
Additional information about this product’s authorization can be found on the FDA Website.
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Documentation Links
Documentation Links
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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:
MTRX-C19+Flu-25PK : 87636QW
MTRX-C19+FLU-B1 : 87636QW
Link: 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.
Manufacturer contact information for current product:
Sekisui Diagnostics:
https://sekisuidiagnostics.com/contact-us/.
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:
MTRX-C19+Flu-25PK : 87636QW
MTRX-C19+FLU-B1 : 87636QW
Link: 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.
Manufacturer contact information for current product:
Sekisui Diagnostics:
https://sekisuidiagnostics.com/contact-us/.
