| Primary Device ID | M90171108B1 |
| NIH Device Record Key | dc5124d6-910c-4858-bdc7-72e9d2e11107 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickProfile™ 2019-nCoV IgG/IgM Antibody Test |
| Version Model Number | 71108B |
| Catalog Number | 71108B |
| Company DUNS | 790175165 |
| Company Name | LUMIQUICK DIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 408-855-0061 |
| udi@lumiquick.com | |
| Phone | 408-855-0061 |
| udi@lumiquick.com | |
| Phone | 408-855-0061 |
| udi@lumiquick.com | |
| Phone | 408-855-0061 |
| udi@lumiquick.com | |
| Phone | 408-855-0061 |
| udi@lumiquick.com | |
| Phone | 408-855-0061 |
| udi@lumiquick.com |
| Length | 80 Millimeter |
| Length | 80 Millimeter |
| Length | 80 Millimeter |
| Length | 80 Millimeter |
| Length | 80 Millimeter |
| Length | 80 Millimeter |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M90171108B0 [Primary] |
| HIBCC | M90171108B1 [Package] Contains: M90171108B0 Package: Kit [25 Units] In Commercial Distribution |
| HIBCC | M90171108B2 [Package] Contains: M90171108B0 Package: BAG [100 Units] In Commercial Distribution |
| QKO | Reagent, Coronavirus Serological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2020-04-03 |
| 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 | 2022-06-10QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus. |
| 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 |