| Primary Device ID | M90107RD70211 | 
| NIH Device Record Key | 5dee32f8-56c9-4195-85fe-374f5311942d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | QuickProfile™ PCP Test Strip | 
| Version Model Number | 07RD7021 | 
| Catalog Number | 07RD7021 | 
| 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 | M90107RD70210 [Primary] | 
| HIBCC | M90107RD70211 [Package] Contains: M90107RD70210 Package: PACK [50 Units] In Commercial Distribution | 
| LCM | Enzyme Immunoassay, Phencyclidine | 
| 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 |