| Primary Device ID | B80088121CDFL500SCP0 |
| NIH Device Record Key | b64f1666-53c6-4370-afac-5bdddd2d2c49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERTIFIED DRUG FREE URINE |
| Version Model Number | 88121-CDF(L)500 SCP |
| Catalog Number | 88121-CDF(L)500 SCP |
| Company DUNS | 092519016 |
| Company Name | UTAK LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B80088121CDFL500SCP0 [Primary] |
| LAS | Drug Specific Control Materials |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-24 |
| Device Publish Date | 2024-04-16 |
| B80004000000010 | 88121-CDF(LCLIN) |
| B80088121CDFL5000 | CERTIFIED DRUG FREE URINE |
| B80088121CDFF155 | CERTIFIED DRUG FREE URINE |
| B800CDFUF400CL0 | CERTIFIED DRUG FREE URINE |
| B800CDFUL250OT0 | CERTIFIED DRUG FREE URINE |
| B800CDFLLTRDSHS0 | CERTIFIED DRUG FREE URINE |
| B800CDFSFUFDOJ0 | CERTIFIED DRUG FREE URINE |
| B800CDFL500JHE0 | CERTIFIED DRUG FREE URINE |
| B800CDFU1LSMA0 | CERTIFIED DRUG FREE URINE |
| B800CDFL500PM0 | CERTIFIED DRUG FREE URINE |
| B80088121CDFL1005 | CERTIFIED DRUG FREE URINE |
| B80088121CDFL4005 | CERTIFIED DRUG FREE URINE |
| B800CDFUF10NJSP5 | CERTIFIED DRUG FREE URINE |
| B800BLKU300SLP5 | CERTIFIED DRUG FREE URINE |
| B80088121CDFF1005 | CERTIFIED DRUG FREE URINE |
| B800BLKUF100MAKO5 | CERTIFIED DRUG FREE URINE |
| B80088121CDFLLTRWVDTL5 | CERTIFIED DRUG FREE URINE |
| B80088121CDFL500SCP0 | CERTIFIED DRUG FREE URINE |