| Primary Device ID | B80010029000030 |
| NIH Device Record Key | 2429257c-b111-4d79-9b17-9944add04309 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRUGS OF ABUSE CAL |
| Version Model Number | DA CAL M LB |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B80010029000030 [Primary] |
| HIBCC | B80010029000031 [Package] Package: Box [4 Units] In Commercial Distribution |
| HIBCC | B80010029000032 [Package] Package: Box [5 Units] In Commercial Distribution |
| HIBCC | B80010029000033 [Package] Package: Box [10 Units] In Commercial Distribution |
| HIBCC | B80010029000036 [Package] Package: Box [25 Units] In Commercial Distribution |
| HIBCC | B80010029000037 [Package] Package: Box [50 Units] In Commercial Distribution |
| HIBCC | B80010029000038 [Package] Package: Box [100 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 | 2022-05-12 |
| Device Publish Date | 2022-05-04 |
| B80010029000011 | DA+ CAL M LB |
| B80010029000030 | DA CAL M LB |
| B800DAMCALRDL5 | DRUGS OF ABUSE CAL |