-
,for, Item ID-
- #1301525
- Sekisui Diagnostics #1099
Respiratory Test Kit OSOM® COVID-19 / Flu A + B Combo Test 25 Tests CLIA Waived
TEST, RESPTRY 510K CLIA F/COVID-19/FLU A&B (25/KT 18KT/CS)
Features
- OSOM® COVID-19/Flu A&B Combo Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection
- All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management
- Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions
- More …
Product Details Email
Product Specifications
| McKesson # | 1301525 |
|---|---|
| Manufacturer # | 1099 |
| Brand or Series | OSOM® |
| Manufacturer Name | Sekisui Diagnostics |
| Application | Respiratory Test Kit |
| Buy American Act (BAA) Compliant | No |
| CLIA Classification | CLIA Waived |
| CLIA Classified | CLIA Waived |
| Contents 1 | (27) Test Devices, (27) Empty Reagent Tubes, (27) Ampules containing Extraction Buffer, (27) Sample Collection Swabs, (1) Positive Control Swab, (1) Negative Control Swab, (1) Tube Holder, IFU, Quick Ref Guide |
| Manufacturer Number | 1099 |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 60 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Visual Read |
| Sample Type | Anterior Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Test Device Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow |
| Test Name | COVID-19 / Flu A + B Combo Test |
| Time to Results | 15 Minute Results |
| Trade Agreement Act (TAA) Compliant | No |
Features
- OSOM® COVID-19/Flu A&B Combo Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection
- All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management
- Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions
- Positive results do not rule out bacterial infection or co-infection with other viruses
- The test strip enclosed in a cassette housing is comprised of the following components: sample pad, reagent pad, biotin pad, reaction membrane, and absorbent pad
- CLIA waived for use with anterior nasal swab samples
More Information
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