RT3 LEVEL 3 RT3 3 S F PG

GUDID B800RT33SFPG5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B800RT33SFPG5
NIH Device Record Key	b1995516-92af-4244-8674-bca49cb049fa
Commercial Distribution Status	In Commercial Distribution
Brand Name	RT3 LEVEL 3
Version Model Number	RT3 3 S F PG
Catalog Number	RT3 3 S F PG
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	B800RT33SFPG0 [Primary]
HIBCC	B800RT33SFPG5 [Package] Contains: B800RT33SFPG0 Package: BOX [20 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

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B800MDLABS43V2LOW5 - MD LABS 43 DRUGS LOW	2025-01-21 MD LABS 43 DRUGS LOW
B800DOA1EXTBUFOFFMMC5 - DRUGS OF ABUSE LEVEL 1	2025-01-20 DRUGS OF ABUSE LEVEL 1
B800DOA2EXTBUFOFFMMC5 - DRUGS OF ABUSE LEVEL 2	2025-01-20 DRUGS OF ABUSE LEVEL 2