ENDO LEVEL 3 STER 3 SMXS F SRL

GUDID B800STER3SMXSFSRL5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B800STER3SMXSFSRL5
NIH Device Record Key	f88a4f92-731b-42fe-a3ec-a57c0f586d40
Commercial Distribution Status	In Commercial Distribution
Brand Name	ENDO LEVEL 3
Version Model Number	STER 3 SMXS F SRL
Catalog Number	STER 3 SMXS F SRL
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

Device Issuing Agency	Device ID
HIBCC	B800STER3SMXSFSRL0 [Primary]
HIBCC	B800STER3SMXSFSRL5 [Package] Contains: B800STER3SMXSFSRL0 Package: [50 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

B800STER1SMXSFSRL5 - ENDO LEVEL 1	2025-04-23 ENDO LEVEL 1
B800STER2SMXSFSRL5 - ENDO LEVEL 2	2025-04-23 ENDO LEVEL 2
B800STER3SMXSFSRL5 - ENDO LEVEL 3	2025-04-23ENDO LEVEL 3
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