Neonatal GALT kit NG-1100

GUDID 06438147001262

For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried blood. Note: Kit contains multiple packages.

Wallac Oy

Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescence
Primary Device ID06438147001262
NIH Device Record Key0aba8d0e-8473-4cc6-9900-16cf266f49a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeonatal GALT kit
Version Model NumberNG-1100
Catalog NumberNG-1100
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
GS106438147001262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

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 Date2016-02-02

On-Brand Devices [Neonatal GALT kit]

06438147001279For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried b
06438147001262For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried b

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.