LUMIQUICK DIAGNOSTICS, INC. 1N40C5-1-US-BS Rapid SARS-CoV-2 Antigen Test Card
Company Name
LUMIQUICK DIAGNOSTICS, INC.
Catalog Number
1N40C5-1-US-BS
Description
The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
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Additional Details
Device Identifier
00855636003716
Is RX
No
Is Over the Counter
Yes
Requires Sterilization
No
Is Sterile
Yes
Is Single Use
Yes
Barcode Mapping
| Unit of Measurement | Eaches | GTIN |
|---|---|---|
| Each | 1 | 00855636003716 |
| Kit of 2 | 2 | 00855636003723 |
| Kit of 4 | 4 | 00855636003730 |
| Kit of 5 | 5 | 00855636003747 |
| Kit of 8 | 8 | 00855636003754 |
| Kit of 10 | 10 | 00855636003761 |
| Kit of 20 | 20 | 00855636003778 |
| Kit of 40 | 40 | 00855636003785 |