GSP Neonatal Biotinidase kit 3307-001U

GUDID 06438147330911

For the quantitative determination of human biotinidase activity in dried blood. Note: Kit contains multiple packages.

Wallac Oy

Biotinidase IVD, kit, enzyme fluorescence
Primary Device ID06438147330911
NIH Device Record Key80d84c78-40b7-4491-8a7a-f7e8f3db9327
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSP Neonatal Biotinidase kit
Version Model Number3307-001U
Catalog Number3307-001U
Company DUNS540156544
Company NameWallac Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147330911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAKSystem,Test,Biotinidase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-12

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