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Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test

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Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test (Pro)

For In Vitro Diagnostic Use Only.
For Professional Use.

The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza and SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

Key Benefits:

  • Detect 3 viruses at once (SARS-CoV-2, Flu A&B)
  • Two result windows for easy readability.
  • Shallow nasal swab sample collection.
  • Suitable for 2+ years old.
  • Swabbing should be performed by an adult for children aged 2 to 13. User must be aged 14 + to perform self test.

Specifications:

  • Specimen: Nasal Swab
  • Time to results: 15 minutes
  • Stability: 24 months
  • Storage: 36-86°F (2-30°C)

Positive Results

COVID-19 Positive
Flu A Positive
Flu B Positive
COVID-19 & Flu A Positive
COVID-19 & Flu B Positive
COVID-19, Flu A, & Flu B Positive
Flu A & Flu B Positive

Negative Result

Negative Result

Invalid Results

Invalid Result 1
Invalid Result 2
Invalid Result 3
Invalid Result 4
Invalid Result 5
Invalid Result 6
Invalid Result 7
Invalid Result 8
Invalid Result 9
Invalid Result 10
Invalid Result 11
Invalid Result 12
Invalid Result 13
Invalid Result 14
Invalid Result 15
Invalid Result 16
Invalid Result 17
Invalid Result 18
Invalid Result 19
Invalid Result 20
Invalid Result 21
Invalid Result 22
Invalid Result 23
Invalid Result 23
Invalid Result 24
Invalid Result 24

Ordering Information:

Product DescriptionSpecimenCatalog No.Kit SizeRegulatory Clearance
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test ProNasal Swab
GCFC-525SKa-10T10 Test/kit
510(k)
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test ProNasal Swab
GCFC-525SKa-25T25 Test/kit510(k)
External Controls:
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro		GCFC-PNK21 Positive Control Swab
1 Negative Control Swab		FDA Exempt
External Controls:
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro		GCFC-PNK2010 Positive Control Swab
10 Negative Control Swab		FDA Exempt
External Controls:
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro		GCFC-PNK4020 Positive Control Swab
20 Negative Control Swab		FDA Exempt
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