Iduronate 2-sulfatase S&IS 4400-0010

GUDID 06438147386963

Assay development analyte-specific reagent IVD

Primary Device ID	06438147386963
NIH Device Record Key	0daa672c-80b1-4758-8728-663a3f999eca
Commercial Distribution Status	In Commercial Distribution
Brand Name	Iduronate 2-sulfatase S&IS
Version Model Number	4400-0010
Catalog Number	4400-0010
Company DUNS	540156544
Company Name	Wallac Oy
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	true
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	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and -16 Degrees Celsius

Device Issuing Agency	Device ID
GS1	06438147386963 [Primary]

MVU	Reagents, Specific, Analyte

Steralize Prior To Use	false
Device Is Sterile	false

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