Rapid SARS-CoV-2 Antigen Test Card - The Rapid SARS-CoV-2 Antigen Test Card is a - LUMIQUICK DIAGNOSTICS, INC.

Duns Number:790175165

Device Description: The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic 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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More Product Details

Catalog Number

1N40C5-1-US-BS

Brand Name

Rapid SARS-CoV-2 Antigen Test Card

Version/Model Number

1N40C5-1-US-BS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

QKP

Product Code Name

Coronavirus Antigen Detection Test System.

Device Record Status

Public Device Record Key

fad87d12-433c-46aa-a16f-606d478d28f3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 12, 2022

Additional Identifiers

Package DI Number

00855636003723

Quantity per Package

2

Contains DI Package

00855636003716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit

"LUMIQUICK DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 117
U Unclassified 2