| Primary Device ID | 00855636003808 |
| NIH Device Record Key | 5580ae29-4238-4318-9912-9415264590f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickProfile™ Covid-19/FluA&B Antigen Combo Test |
| Version Model Number | 71118-1T |
| Catalog Number | 71118-1T |
| Company DUNS | 790175165 |
| Company Name | LUMIQUICK DIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855636003808 [Primary] |
| GS1 | 00855636003815 [Package] Package: KIT [2 Units] In Commercial Distribution |
| GS1 | 00855636003822 [Package] Package: KIT [4 Units] In Commercial Distribution |
| GS1 | 00855636003839 [Package] Package: KIT [5 Units] In Commercial Distribution |
| GS1 | 00855636003846 [Package] Package: KIT [8 Units] In Commercial Distribution |
| GS1 | 00855636003853 [Package] Package: KIT [20 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 | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
| 00855636003808 - QuickProfile™ Covid-19/FluA&B Antigen Combo Test | 2023-09-11The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. |
| 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 | 2022-04-20 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 |