AccessGUDID - DEVICE: Neonatal GALT kit (06438147001262)

GUDID

Device Identifier (DI) Information

Brand Name: Neonatal GALT kit
Version or Model: NG-1100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NG-1100
Company Name: Wallac Oy

Primary DI Number: 06438147001262
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60271	Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the quantitative measurement of galactose-1-phosphate uridyl transferase (G1PUT), also known as galactose transferase (GALT) enzyme, in a clinical specimen, using an enzyme fluorescence method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQP	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950803	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between -30 and -16 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0aba8d0e-8473-4cc6-9900-16cf266f49a7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 02, 2016