PETH LEVEL 3 PETH 3 V3 WB F MAYO

GUDID B800PETH3V3WBFMAYO5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B800PETH3V3WBFMAYO5
NIH Device Record Key	fb88040c-5bae-466c-b0be-e3d5d65eb498
Commercial Distribution Status	In Commercial Distribution
Brand Name	PETH LEVEL 3
Version Model Number	PETH 3 V3 WB F MAYO
Catalog Number	PETH 3 V3 WB F MAYO
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
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B800PETH3V3WBFMAYO0 [Primary]
HIBCC	B800PETH3V3WBFMAYO5 [Package] Contains: B800PETH3V3WBFMAYO0 Package: BOX [81 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false