Primary Device ID | B800POS2062U0 |
NIH Device Record Key | 281b7768-5922-4143-94f3-3a93767b480e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BENZOYLECGONINE POS |
Version Model Number | POS-206-2U |
Catalog Number | POS-206-2U |
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 | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 Milliliter |
Total Volume | 2 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 | B800POS2062U0 [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 | 2025-03-03 |
Device Publish Date | 2025-02-21 |
B800STER1SMXSFSRL5 - ENDO LEVEL 1 | 2025-04-23 ENDO LEVEL 1 |
B800STER2SMXSFSRL5 - ENDO LEVEL 2 | 2025-04-23 ENDO LEVEL 2 |
B800STER3SMXSFSRL5 - ENDO LEVEL 3 | 2025-04-23 ENDO LEVEL 3 |
B800SMXCSFFCP5 - SMX CEREBRAL SPINAL FLUID 1ML | 2025-04-10 SMX CEREBRAL SPINAL FLUID 1ML |
B800DAUQC1V2FBILH5 - DRUGS OF ABUSE QC 1 | 2025-04-09 DRUGS OF ABUSE QC 1 |
B800DAUQC3V2FBILH5 - DRUGS OF ABUSE QC 3 | 2025-04-09 DRUGS OF ABUSE QC 3 |
B800DAQCHIGHUFUMHC5 - DRUGS OF ABUSE QC HIGH | 2025-04-07 DRUGS OF ABUSE QC HIGH |
B800DAQCLOWUFUMHC5 - DRUGS OF ABUSE QC LOW | 2025-04-07 DRUGS OF ABUSE QC LOW |