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)
5. December 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)
8. December 2021
WIZ 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 Test Nasal Test (1 pack)
Details:
- Sensitivity: 95.91%
- Specificity: 100.00%
- Special approval BfArM 5640-S-210/21
- BfArM certified AT296 / 21
- Paul Ehrlich Institute evaluates
- Manufacturer: Xiamen Wiz Biotech Co.Ltd.
Specification:
- Test time: 15 minutes
- Sample type: nasal swab
Scope of delivery:
- 1x test cassette
- 1x sterile swab for pharynx swab
- 1x extraction buffer container
- 1x buffer solution
- 1x instructions for use
Most important properties:
- The SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is only intended for in-vitro diagnostics.
- This test kit is only used for the qualitative detection of SARS-CoV-2 antigens (nucleocapsid protein) in nasal swab samples (anterior nasal cavity) and it is strictly forbidden to collect samples from other parts of the body.
- People under the age of 18 should be tested with the help of a legal guardian.
- Before you decide to carry out relevant treatment or measures, it is recommended to contact general practitioners or specialists in order to avoid endangering yourself or others.
- Find out about current measures and regulations in your countries, and take measures according to official information to protect yourself and others effectively.
Excerpt from the instructions for use:
- For the qualitative in vitro detection of new coronavirus antigen (nucleocapsid protein) in nasal swab samples (anterior nasal cavity) from patients suspected of having a new coronavirus infection within the first 7 days after the onset of symptoms. It can be used in home tests (amateur use).
- A positive result indicates that the sample contains a new coronavirus antigen. However, the 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 main cause of the disease.
- A negative result does not rule out a 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 the new coronavirus pneumonia and, if necessary, confirm them with nucleic acid test reagents to further treat the patient.
Notes on sales by PSA partners
Due to the special approval, the sale via PSA partners can also take place to private individuals . In addition to purchasing smaller quantities of 10 or more, we also accept inquiries for wholesalers. Accordingly, we supply a large customer base who forwards these tests for laypersons to the respective end customers.
Do you have further questions about our offer? Talk to us and we will be happy to help you. Order the rapid test approved by the BfArM and other high-quality protective equipment from PSA partners.
Why PSA-Partner?
- Certified PPE Shop
- Best ratings on the web
- Fair and transparent prices
- Payment on account
- No waiting time - only stock goods
- Best references
| Quantity | 100, 200, 400, 1200, 2400, 4800, 9600, 19200, 38400 |
|---|
Note for companies
As a result of an amendment to the Medical Devices Dispensing Ordinance (MPAV), since February 2, 2021, companies and facilities 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 coronavirus SARS-CoV-2.
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 the advice of the respective company medical service or the employers’ liability insurance association.
Why PSA-Partner?
- Certified PPE Shop
- Best ratings on the web
- Fair and transparent prices
- Payment on account
- No waiting time - only stock goods
- Best references
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