| Primary Device ID | 00817830020685 |
| NIH Device Record Key | 6790ca47-f660-49c1-8cdd-79770677e3fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOA 1 PANEL TEST |
| Version Model Number | 07RD7060-04 |
| Catalog Number | 07RD7060-04 |
| Company DUNS | 008028248 |
| Company Name | RAPID 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(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.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 |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817830020685 [Primary] |
| DIO | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-20 |
| 00817830020760 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP |
| 00817830020753 | Immunoassay for the detection of the following drug substance(s) in human urine: THC |
| 00817830020746 | Immunoassay for the detection of the following drug substance(s) in human urine: PCP |
| 00817830020739 | Immunoassay for the detection of the following drug substance(s) in human urine: OXY |
| 00817830020722 | Immunoassay for the detection of the following drug substance(s) in human urine: OPI-II |
| 00817830020715 | Immunoassay for the detection of the following drug substance(s) in human urine: OPI |
| 00817830020708 | Immunoassay for the detection of the following drug substance(s) in human urine: MTD |
| 00817830020692 | Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP |
| 00817830020685 | Immunoassay for the detection of the following drug substance(s) in human urine: COC |
| 00817830020678 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD |
| 00817830020661 | Immunoassay for the detection of the following drug substance(s) in human urine: BAR |
| 00817830020654 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP |