| Primary Device ID | B800DAUNEGV2UFPHHC5 |
| NIH Device Record Key | b6199520-2389-439e-886d-1f5a5b9659f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRUGS OF ABUSE NEGATIVE SCREEN V2 |
| Version Model Number | DAU NEG V2 U F PHHC |
| Catalog Number | DAU NEG V2 U F PHHC |
| 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 | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800DAUNEGV2UFPHHC0 [Primary] |
| HIBCC | B800DAUNEGV2UFPHHC5 [Package] Contains: B800DAUNEGV2UFPHHC0 Package: box [20 Units] In Commercial Distribution |
| 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 |
| B80088121CDFF100PDH5 - CERTIFIED DRUG FREE URINE 100ML | 2024-05-08 CERTIFIED DRUG FREE URINE 100ML |
| B800C1011L1V45 - CARBAMAZEPINE-10,11-EPOXIDE LEVEL 1 | 2024-05-08 CARBAMAZEPINE-10,11-EPOXIDE LEVEL 1 |
| B800C1011L2V45 - CARBAMAZEPINE-10,11-EPOXIDE LEVEL 2 | 2024-05-08 CARBAMAZEPINE-10,11-EPOXIDE LEVEL 2 |
| B800C1011L3V45 - CARBAMAZEPINE-10,11-EPOXIDE LEVEL 3 | 2024-05-08 CARBAMAZEPINE-10,11-EPOXIDE LEVEL 3 |
| B800LEFLUHIGHL1V25 - LEFLUNOMIDE HIGH LEVEL 1 | 2024-05-08 LEFLUNOMIDE HIGH LEVEL 1 |
| B800LEFLUHIGHL2V25 - LEFLUNOMIDE HIGH LEVEL 2 | 2024-05-08 LEFLUNOMIDE HIGH LEVEL 2 |
| B800LEFLUHIGHL3V25 - LEFLUNOMIDE HIGH LEVEL 3 | 2024-05-08 LEFLUNOMIDE HIGH LEVEL 3 |
| B800HPROG1SFFUMC5 - HYDROXYPROGESTERONE LEVEL 1 | 2024-05-07 HYDROXYPROGESTERONE LEVEL 1 |