Mesa BioTech Inc Respiratory Test Kit Accula™ Real-Time PCR SARS-CoV-2 Nasal Swab / Nasal Mid-Turbinate Swab Sample 25 Tests CLIA Waived for Point of Care - KT/1 - COV4100-KT
Mesa BioTech Inc Respiratory Test Kit Accula™ Real-Time PCR SARS-CoV-2 Nasal Swab / Nasal Mid-Turbinate Swab Sample 25 Tests CLIA Waived for Point of Care - KT/1 - COV4100-KT
Regular price
$2,075.99
Sale price
$2,075.99
Regular price
Unit price
per
Shipping calculated at checkout.
50 In stock
Estimated deliver:
Flat-Rate Shipping from $8.25
Mesa BioTech Inc Respiratory Test Kit Accula™ Real-Time PCR SARS-CoV-2 Nasal Swab / Nasal Mid-Tur...
| Item Id | 1207812 |
| MF Id# | COV4100 |
| Brand | Accula™ |
| Manufacturer | Mesa BioTech Inc |
| Country of Origin | Unknown |
| Application | Respiratory Test Kit |
| CLIA Classification | CLIA Waived for Point of Care |
| CLIA Classified | CLIA Waived Sample Dependent |
| Contents 1 | (25) Sterile Collection Swabs, (25) 5 mL Buffer Solution, (25) Test Cassettes, (25) Transfer Pipettes, Positive Control Swab High, Positive Control Swab Low, Negative Control Swab, Instructions for Use, Quick Reference Guide |
| For Use With | For use with the Accula™ Dock and Silaris™ Dock |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab / Nasal Mid-Turbinate Swab Sample |
| Specialty | Molecular |
| Technology | PCR / Lateral Flow Technology |
| Test Format | Cassette Format |
| Test Name | SARS-CoV-2 |
| Test Type | Real-Time PCR |
| Time to Results | 30 Minute Results |
| UNSPSC Code | 41116205 |
Features
- Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Product ships with minimum 30 days dating
- The Accula SARS-CoV-2 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
- Testing is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests
- The Accula™ SARS-CoV-2 Test performed on the Accula Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider
- Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient 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
- Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information
- The Accula SARS-CoV-2 Test is intended for use by trained operators who are proficient in performing tests on the Accula Dock and Silaris Dock
- Materials provided separately: Accula Dock (Catalog # D2000) or Silaris Dock (Catalog #1026), Accula SARS-CoV-2 Control Kit (Catalog #COV4100-1)
- Accurate results - Positive percent agreement (PPA) 95.8% to 100% and negative percent agreement 100% in prospective and retrospective clinical studies