| Primary Device ID | 00817830020852 |
| NIH Device Record Key | ce1bfdc4-87e2-4443-b896-5fe867616f98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOA 3 PANEL TEST |
| Version Model Number | 07RD7062-06 |
| Catalog Number | 07RD7062-06 |
| 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 | 00817830020852 [Primary] |
| DJR | ENZYME IMMUNOASSAY, METHADONE |
| 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 |
| 00817830021002 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A |
| 00817830020999 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / THC |
| 00817830020982 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / OPI-II / |
| 00817830020975 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / OPI / THC |
| 00817830020968 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / OPI / THC |
| 00817830020951 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / MTD / OPI |
| 00817830020944 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / MTD / OPI |
| 00817830020937 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI |
| 00817830020920 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI |
| 00817830020913 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / OPI |
| 00817830020906 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / OPI |
| 00817830020890 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / M-A |
| 00817830020883 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / MTD |
| 00817830020876 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / THC |
| 00817830020869 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI |
| 00817830020852 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI |
| 00817830020845 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI |
| 00817830020838 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI |
| 00817830020821 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI-II / |
| 00817830020814 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC |
| 00817830020807 | Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-II |
| 00817830020791 | Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI / T |
| 00817830020784 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / T |
| 00817830020777 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / THC |