Respiratory Test Kit OSOM COVID-19 Antigen 40 Tests

Key Features

SKU: SEK-1066-40
Condition: Factory New
Learn more:

Contact The Manufacturer

MFR: Sekisui Diagnostics Ships from MFI Medical
MPN: 1066-40

$3,079.26

Special Order Item

Est. Delivery:

Quantity

<p>Earn%20[points_amount]%20when%20completing%20this%20purchase.</p>

Shop with Confidence

+

Description

OSOM Covid-19 Antigen Rapid Test is for use under an FDA EUA:
OSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct midturbinate (MT) nasal swab specimens from individuals who are suspected of COVID-19
Qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests
For laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests
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
Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine patient infection status
Positive results do not rule out bacterial infection or co-infection with other viruses
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks

Product Specs

Item Number	1232792
Catalog Number	1066-40
UOM	CS
Level 1 Family Description	Lab-Waived Lab
Level 2 Category Description	Lab-Respiratory Testing
Level 3 Group Description	COVID Testing
Level 4 Sub-Category Description	COVID - Rapids
Application	Respiratory Test Kit
Brand	OSOM
Buy American Act (BAA) Compliant	No
Contents 1	(40) Test Devices containing LFI Test Strip in Plastic Housing, 2 X (20) Nasal Swab Specimen Collection and Dispensing Tubes with OSOM Antigen Buffer, IFU, Quick Ref Guide
Country of Origin	Unknown
Is_ECAT	N
Is_GSA	Y
Is_VA	N
Manufacturer	Sekisui Diagnostics
Manufacturer #	1066-40
McKesson #	1232792
Number of Tests	40 Tests
Purchase Program Type	Standard Purchase
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
Trade Agreement Act (TAA) Compliant	No
UNSPSC Code	41116144