HIGH RANGE TRACE ELEMENTS V3 66815 V3 HR LC

GUDID B80066815V3HRLC5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B80066815V3HRLC5
NIH Device Record Key	4b4b7482-7a8f-4bef-8c98-f8c4e881638f
Commercial Distribution Status	In Commercial Distribution
Brand Name	HIGH RANGE TRACE ELEMENTS V3
Version Model Number	66815 V3 HR LC
Catalog Number	66815 V3 HR LC
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

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	B80066815V3HRLC0 [Primary]
HIBCC	B80066815V3HRLC5 [Package] Contains: B80066815V3HRLC0 Package: BOX [5 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

B800ETH177WBFOSBI5 - ETHANOL 76 MG/DL	2026-03-03 ETHANOL 76 MG/DL
B800ETH76WBFOSBI5 - ETHANOL 76 MG/DL	2026-03-03 ETHANOL 76 MG/DL
B800ANTIF2SQD5 - ANTIFUNGALS LEVEL 2	2026-02-16 ANTIFUNGALS LEVEL 2
B800ANLCCALMFFCCO5 - ANLC CAL	2026-02-13 ANLC CAL
B800CONTROL1V2SSH5 - MIXED CONTROL LEVEL 1 V2	2026-02-13 MIXED CONTROL LEVEL 1 V2
B800CONTROL2V2SSH0 - MIXED CONTROL LEVEL 2 V2	2026-02-13 MIXED CONTROL LEVEL 2 V2
B800DAUCONT1V2FRX5 - DAU CONTROL LEVEL 1 V2	2026-02-13 DAU CONTROL LEVEL 1 V2
B800DAUCONT2V2FRX0 - DAU CONTROL LEVEL 2 V2	2026-02-13 DAU CONTROL LEVEL 2 V2