| Primary Device ID | 00855636003723 |
| NIH Device Record Key | fad87d12-433c-46aa-a16f-606d478d28f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rapid SARS-CoV-2 Antigen Test Card |
| Version Model Number | 1N40C5-1-US-BS |
| Catalog Number | 1N40C5-1-US-BS |
| Company DUNS | 790175165 |
| Company Name | LUMIQUICK DIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com | |
| Phone | 4088550061 |
| info@lumiquick.com |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855636003716 [Primary] |
| GS1 | 00855636003723 [Package] Contains: 00855636003716 Package: Kit [2 Units] In Commercial Distribution |
| GS1 | 00855636003730 [Package] Contains: 00855636003716 Package: Kit [4 Units] In Commercial Distribution |
| GS1 | 00855636003747 [Package] Contains: 00855636003716 Package: Kit [5 Units] In Commercial Distribution |
| GS1 | 00855636003754 [Package] Contains: 00855636003716 Package: Kit [8 Units] In Commercial Distribution |
| GS1 | 00855636003761 [Package] Contains: 00855636003716 Package: Kit [10 Units] In Commercial Distribution |
| GS1 | 00855636003778 [Package] Contains: 00855636003716 Package: Kit [20 Units] In Commercial Distribution |
| GS1 | 00855636003785 [Package] Contains: 00855636003716 Package: Kit [40 Units] In Commercial Distribution |
| QKP | Coronavirus Antigen Detection Test System. |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-20 |
| Device Publish Date | 2022-04-12 |
| 00855636003808 - QuickProfile™ Covid-19/FluA&B Antigen Combo Test | 2023-09-11 The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differ |
| M90107RD7205100 - QuickProfile™ Drugs of Abuse Test Cup | 2022-07-20 Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / M-AMP / OPI / THC |
| M90171108B1 - QuickProfile™ 2019-nCoV IgG/IgM Antibody Test | 2022-06-10 QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapi |
| 00855636003723 - Rapid SARS-CoV-2 Antigen Test Card | 2022-04-20The 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. |
| 00855636003723 - Rapid SARS-CoV-2 Antigen Test Card | 2022-04-20 The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitati |
| M09107RD7065221 - QuickProfile™ Drugs of Abuse Panel 6 Test | 2021-05-24 Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY / THC |
| M90107RD70051 - QuickProfile™ Methamphetamine Test Strip | 2021-05-24 Immunoassay for the detection of methamphetamine in human urine |
| M90107RD70060 - QuickProfile™ Methamphetamine Test Card | 2021-05-24 Immunoassay for the detection of methamphetamine in human urine |
| M90107RD70071 - QuickProfile™ Cocaine Test Strip | 2021-05-24 Immunoassay for the detection of cocaine in human urine |