
Deepblue Medical Anhui COVID-19 / SARS-COV-2 Antigen Rapid Test LOLLY Layman's Test, Approval Private Use / Layman's Own Use, CE1434, BfArM Listing (Reimbursable) (1 Test per Box)
December 5, 2021
AmonMed COVID-19 / SARS-COV-2 Antigen Rapid Test Lollipop Test, Approval Private Use / Self-administration by Lay Persons, CE1434, BfArM Listing (reimbursable) - PZN: 17897081 (1 test per box)
December 8, 2021WIZ Biotech COVID-19 / SARS-COV-2 Antigen Rapid Nasal Test, Approval Private Use / Self-administration by Lay Persons, CE1434, BfArM Listing (reimbursable), PEI evaluated (1 test per box)
WIZ Biotech COVID-19 / SARS-COV-2 Antigen Rapid Nasal Test (Pack of 1)
Details:
- Sensitivity: 95.91%
- Specificity: 100.00%
- Special approval BfArM 5640-S-210/21
- BfArM certified AT296/21
- Paul Ehrlich Institute evaluated
- Manufacturer: Xiamen Wiz Biotech Co.Ltd.
Specification:
- Test time: 15 minutes
- Specimen type: Nasal swab
Scope of delivery:
- 1x test cassette
- 1x sterile swab for pharyngeal smear
- 1x extraction buffer container
- 1x buffer solution
- 1x instruction manual
Main features:
- The SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is intended for in vitro diagnostic use only.
- This test kit is only used for qualitative detection of SARS-CoV-2 antigens (nucleocapsid protein) in nasal swab specimens (anterior nasal cavity), and it is strictly prohibited to collect specimens from other body parts.
- Persons under 18 years of age should be tested with the assistance of a parent or guardian.
- Before deciding to undertake any relevant treatment or action, it is recommended that you contact primary care physicians or professionals to avoid putting yourself or others at risk.
- Find out about current policies and regulations in your countries, and take action according to official information to effectively protect yourself and others.
Extract from the instructions for use:
- For the qualitative in vitro detection of new coronavirus antigen (nucleocapsid protein) in nasal swab specimens (anterior nasal cavity) from patients with suspected new coronavirus infection within the first 7 days of symptom onset. It can be used in home tests (lay use).
- A positive result indicates that the specimen contains a new coronavirus antigen. However, medical history and other diagnostic information should be combined to definitively confirm whether one is infected with the new coronavirus.
- A positive result does not rule out co-infection with bacteria or other viruses, and the pathogen detected may not be the primary cause of the disease.
- A negative result does not rule out new coronavirus infection, nor should it be used as the sole basis for treatment or patient management decisions (including infection control decisions).
- Negative results should take into account the recent contact history, the patient's medical history, and the same signs and symptoms of new coronavirus pneumonia and confirm with nucleic acid test reagents, if necessary, to further treat the patient.
Notes on sales by PSA partners
Do you have any further questions about our range? Contact us and we will be happy to help you. Order the BfArM-registered rapid test and other high-quality protective equipment from PSA-Partner now.
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- Certified PPE store
- Best ratings on the net
- Fair and transparent prices
- Payment on account
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Trusted Shops Reviews:
Quantity | 100, 200, 400, 1200, 2400, 4800, 9600, 19200, 38400 |
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Note for companies
As a result of an amendment to the Medical Devices Dispensing Ordinance (MPAV), as of February 2, 2021, companies and institutions that provide a service to the general public, the failure or impairment of which would lead to significant supply bottlenecks or endanger public safety, may also obtain and use rapid antigen tests for the detection of the SARS-CoV-2 coronavirus.
In concrete terms, this means that these companies and facilities can offer regular testing for their employees and visitors and make these tests part of their hygiene and protection concept, ideally with advice from the respective company medical service or the employers' liability insurance association.
Why PSA Partner?
- Certified PPE store
- Best ratings on the net
- Fair and transparent prices
- Payment on account
- No waiting times - only stock items
- Best references
Trusted Shops Reviews:
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