Primary Device ID | B800CALVS3FMACL5 |
NIH Device Record Key | 91a37fba-6bc9-4779-86f8-6ca78a72cb6c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CALIBRATOR VS 3 |
Version Model Number | CAL VS 3 F M ACL |
Catalog Number | CAL VS 3 F M ACL |
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 | false |
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 | B800CALVS3FMACL0 [Primary] |
HIBCC | B800CALVS3FMACL5 [Package] Contains: B800CALVS3FMACL0 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 | 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 |