Primary Device ID | B30001346000010 |
NIH Device Record Key | 655e439b-3882-42b8-96d1-c2f6233aa1ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | URINE BROAD PANEL HIGH |
Version Model Number | UBP H F V DU |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B30001346000010 [Primary] |
HIBCC | B30001346000011 [Package] Package: Box [4 Units] In Commercial Distribution |
HIBCC | B30001346000012 [Package] Package: Box [5 Units] In Commercial Distribution |
HIBCC | B30001346000013 [Package] Package: Box [10 Units] In Commercial Distribution |
HIBCC | B30001346000016 [Package] Package: Box [25 Units] In Commercial Distribution |
HIBCC | B30001346000017 [Package] Package: Box [50 Units] In Commercial Distribution |
HIBCC | B30001346000018 [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 | 2022-05-11 |
Device Publish Date | 2022-05-03 |
B30001346000010 | UBP H F V DU |
B800UBPHFVDU5 | URINE BROAD PANEL HIGH |
B800UBPHFDU5 | URINE BROAD PANEL HIGH |