Rally #196-1-3625
LifeSign #36025
Status Flu A & B Test (25/KT)
Rapid Test, Flu A&B, Immunoassay, Rx Only, CLIA Complexity: Moderate - NP Wash/Aspirate Samples, Waived - Nasal and Nasopharyngeal Swabs
Features
- Clia Waived For Nasal Swab And Nasopharyngeal Swab Specimens
- Rapid Diagnosis For Early Treatment
- 25 Test Kit
- Innovative Flip Test Design
- Easy-To-Read Cassette
- Pre-Measured Extraction Reagent Capsule For Increased Accuracy and Ease Of Use
- Flocked Nasal Swabs Included For Better Specimen Collection
- Detects H1N1 (Swine Flu)
Negative test results are presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Important Notes
- For In Vitro Diagnostic Use
- For Rx Use Only
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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Status Flu A & B vs. PCR
| Rally # | 196-1-3625 |
| Manufacturer # | 36025 |
| Brand | Status |
| Manufacturer | LifeSign / Princeton BioMeditech |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Complexity | Moderate Complexity with Nasopharyngeal Wash / Aspirate Samples Waived with Nasal / Nasopharyngeal Swabs |
| Number of Tests | 25 Tests |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Name | Influenza A + B |
| Test Type | Immunoassay |
| Time to Results | 10 to 15 Minute Results |
| UNSPSC Code | 41116144 |
| Storage Temperature | 2-30°C (35-86°F) |
| Type | Influenza A | Influenza B |
| Positive Percent Agreement (PPA) | 89.2% (95% CI: 83.0-93.4%) |
86.4% (95% CI: 80.1-90.9%) |
| Negative Percent Agreement (NPA) | 99.4% (95% CI: 97.7-99.8%) |
99.0% (95% CI: 97.1-99.7%) |
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Configurations
Configurations
| Product ID | Description | Quantity |
| 36025 | Status™ Flu A&B | 25 Tests Per Kit |
| 510AS | Nasal Aspirate Kit (44 pipettes, 1 reagent) | 22 Tests Per Kit |
| 36022CS | Status Flu A&B Controls | 5 Sets |
| 36052 | Status A&B Nasal Swab Refill | 52 Per Box |
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- Materials Provided -
Each StatusFlu A&B kit contains enough reagents and materials for 25 tests.
The following components are included in a kit:
- Materials Provided -
Each StatusFlu A&B kit contains enough reagents and materials for 25 tests.
The following components are included in a kit:
- Status Flu A&B test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleoprotein (NP) of influenza A and influenza B. The device is individually pouched.
- Extraction Reagent in capsules (25): For use with swab samples, 300 µL of Phosphate buffer with detergents and preservative
- Sterile Swabs (25): For swab samples
- Positive Control Swab (1): Infl uenza A and B antigens (non-infective recombinant nucleoprotein)
- Negative Control Swab (1): Inactivated Group B Streptococcus antigen (non-infective)
- Package Insert /Instructions for use (1)
- Procedure Card (1)
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Documentation Links
Documentation Links
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