| Primary Device ID | M90107RD70091 |
| NIH Device Record Key | 31979467-6803-407c-b263-424b393f7d15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickProfile™ THC Test Strip |
| Version Model Number | 07RD7009 |
| Catalog Number | 07RD7009 |
| 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 | false |
| 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 | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com | |
| Phone | 1-408-855-0061 |
| udi@lumiquick.com |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 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 |
| 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 |
| 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 | M90107RD70090 [Primary] |
| HIBCC | M90107RD70091 [Package] Contains: M90107RD70090 Package: PACK [50 Units] In Commercial Distribution |
| LDJ | Enzyme Immunoassay, Cannabinoids |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-05-24 |
| Device Publish Date | 2017-11-15 |
| 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 |