| Primary Device ID | M90107RD7064401 | 
| NIH Device Record Key | b9643fe7-0046-4d75-9c99-1d70aa7bf6b0 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | QuickProfile™ Drugs of Abuse Panel 5 Test | 
| Version Model Number | 07RD7064-40 | 
| Catalog Number | 07RD7064-40 | 
| 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 | 
| 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 | 
| M90107RD706403A0 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A | 
| M90107RD7064401 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP /  M-AMP / | 
| M90107RD7064391 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP  / BZD / CO | 
| M90107RD706434A1 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD | 
| M90107RD7064341 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD | 
| M90107RD7064141 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD | 
| M90107RD7064051 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC | 
| M90107RD7064041 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC/ M-AM | 
| M90107RD7064031 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A | 
| M90107RD7064021 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O | 
| M90107RD7064011 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI |