| Primary Device ID | 00817830021033 |
| NIH Device Record Key | 21c1722a-f51c-4bdb-b1ee-8c52e1116e37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOA 4 PANEL TEST |
| Version Model Number | 07RD7063-02 |
| Catalog Number | 07RD7063-02 |
| 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 | 00817830021033 [Primary] |
| DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE |
| 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 |
| 00817830021231 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / M-A |
| 00817830021224 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / MTD |
| 00817830021217 | Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC / OPI |
| 00817830021200 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI |
| 00817830021194 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI |
| 00817830021187 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC |
| 00817830021170 | Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC |
| 00817830021163 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC |
| 00817830021156 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC |
| 00817830021149 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI |
| 00817830021132 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI |
| 00817830021125 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / M-A |
| 00817830021118 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / M-A |
| 00817830021101 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / MTD |
| 00817830021095 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / MTD |
| 00817830021088 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI |
| 00817830021071 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI |
| 00817830021064 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD |
| 00817830021057 | Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD |
| 00817830021040 | Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / O |
| 00817830021033 | Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / O |
| 00817830021026 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI |
| 00817830021019 | Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI |