Orawell (Saliva) – COVID-19 Antigen Rapid Self Test – 1 Test
Orawell (Saliva) – COVID-19 Antigen Rapid Self Test – 1 Test
Orawell (Saliva) – COVID-19 Antigen Rapid Self Test – 1 Test
Orawell (Saliva) – COVID-19 Antigen Rapid Self Test – 1 Test
Orawell (Saliva) – COVID-19 Antigen Rapid Self Test – 1 Test
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 – 1 Test

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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)