WARNINGS
Negative test results do not exclude infection with (so face masks, social distancing and good hygiene practice must be maintained
- Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements (replaces Positive test results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test)
- Always read the label
- Use only as directed
- Use test only one time
- Test within 7 days of symptoms
- Testing by adult only or under adult supervision
- If symptoms persist, talk to your healthcare professional.
Information Regarding Available Support Services Can Also Be Obtained By Contacting Your Local State & Territory Health Department at:
| Australian Capital Territory Department of Health | 02 62077244 | https://www.health.act.gov.au/ |
| New South Wales Department of Health | 137788 | https://www.health.nsw.gov.au/ |
| Northern Territory Department of Health | 1800 020080 | https://www.health.nt.gov.au/ |
| Queensland Department of Health | 134268 | https://www.health.qld.gov.au/ |
| South Australian Department of Health | 1800 253787 | https://www.sahealth.sa.gov.au/ |
| Tasmanian Department of Health | 1800 671738 | https://www.health.tas.gov.au/ |
| Victorian Department of Health | 1800 675398 | https://www.dhhs.vic.gov.au/ |
| Western Australian Department of Health | 1800 595206 | https://www.healthywa.wa.gov.au/ |
If there are poor performance or usability issues use Medical Device Incident Report Call 1800 809361 or E-mail [email protected]
Orawell (Saliva) – COVID-19 Antigen Rapid Self Test – 6 Tests
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The Orawell COVID-19 Ag Rapid Saliva Self-Test Device is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for self-testing purposes, as an aid to the diagnosis of SARS-CoV-2 infection in an individual.
FEATURES:
- Simple All-In-One Test Kit
- Non-invasive – no nose or throat swab required
- Simply rub the kit on the sides of the mouth & place on tongue
- No mixing, spitting, saliva collection or messy procedure required to get result
- Intuitive and easy to use with written and illustrated instructions
- Contents:
- 1x Test device (individually packed in a foil pouch with desiccant)
- 1x Instruction for use
- 1x Biohazard bag
SPECIFICATIONS:
- Format: Test Cassette
- Quantity: 1 Test/Kit
- Time to result: 10-15 Minutes
- Storage Condition: 2-30ºC
- Shelf Life: 24 Months
- Sample: Ag Rapid Saliva
- Simple All-In-One Test Kit
NOTES:
- For self-testing in the home or other environments.
- Negative test results do not exclude infection with SARS-CoV-2 (COVID-19) so face masks, social distancing and good hygiene practice must be maintained.
- Positive test results or any symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
- Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements.
- If symptoms persist, consult your healthcare professional.
- Test kits are singular use and for self-testing purposes only.
- Testing must be performed by adults or under adult supervision.
- All products must be used in accordance with the dedicated package insert and only for its intended purpose as stated.
DISCLAIMER: Negative test results do not exclude infection with SARS-CoV-2 (COVID-19). Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements.
SUGGESTED APPLICATIONS:
This test is authorised for home use in individuals:
- Aged 12 years or older
- Aged 2 – 11 who will have their test supervised by a parent or legal guardian
- Who have experienced covid like symptoms within the last 7 days
Please refer to the attached pdf for instructions for use (IFU) on how to use test:
CERTIFICATIONS:
- Listed on ARTG (ARTG: 377136)
