| Primary Device ID | B800988195 |
| NIH Device Record Key | 736d72cf-0048-454f-93a1-e284d076edec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drugs of Abuse Level 2 |
| Version Model Number | 98819 |
| Catalog Number | 98819 |
| 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 | 888-882-5522 |
| welovecontrol@utak.com |
| Total Volume | 5 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800988190 [Primary] |
| HIBCC | B800988195 [Package] Contains: B800988190 Package: Box [5 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 | 2020-04-23 |
| Device Publish Date | 2020-04-15 |
| B800988195 | Drugs of Abuse Level 2 (WB) |
| B80002041000021 | DRUGS OF ABUSE LEVEL 2 |
| B800DA2WBFRIDH5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAUL2FKA5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAOF2FPM5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2V2FUVMG5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2FAPS5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2V2SAPC5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2FLE5 | DRUGS OF ABUSE LEVEL 2 |
| B800DA2SFLLS0 | DRUGS OF ABUSE LEVEL 2 |
| B800DOA2SMXOFMMC5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAUL2UFVMCI5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2FMED5 | DRUGS OF ABUSE LEVEL 2 |
| B800SMXDAU2FPG5 | DRUGS OF ABUSE LEVEL 2 |
| B800DA2SSH5 | DRUGS OF ABUSE LEVEL 2 |
| B800DA2V2FWBTDHS5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAUQC2FMED5 | DRUGS OF ABUSE LEVEL 2 |
| B800SMXDAU2V2FPG5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2ID5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2FOSUMC5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2FOL5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2FHCMC5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2V2FAPS5 | DRUGS OF ABUSE LEVEL 2 |
| B800DA2V2WBNJSP5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAOF2FADX5 | DRUGS OF ABUSE LEVEL 2 |
| B800DAU2V2NJSP5 | DRUGS OF ABUSE LEVEL 2 |
| B800DOA2I2HEOFFMMC5 | DRUGS OF ABUSE LEVEL 2 |
| B800DOA2EXTBUFOFFMMC5 | DRUGS OF ABUSE LEVEL 2 |