| Primary Device ID | M90107RD7073151 |
| NIH Device Record Key | 6747a08c-7982-4fc9-aca7-e72030c687dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickProfile™ Drugs of Abuse Panel 10 Test |
| Version Model Number | 07RD7073-15 |
| Catalog Number | 07RD7073-15 |
| 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 | M90107RD7073150 [Primary] |
| HIBCC | M90107RD7073151 [Package] Contains: M90107RD7073150 Package: PACK [25 Units] In Commercial Distribution |
| JXM | Enzyme Immunoassay, Benzodiazepine |
| 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 | 2018-02-14 |
| M90107RD7073151 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP |
| M90107RD7073091 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP |
| M90107RD7073081 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP |
| M90107RD7073041 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD |
| M90107RD7073031 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP |
| M90107RD707301A1 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP |
| M90107RD7073011 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP |