AccessGUDID - DEVICE: AutoDELFIA Neonatal Thyroxine (T4) kit (06438147179602)

GUDID

Device Identifier (DI) Information

Brand Name: AutoDELFIA Neonatal Thyroxine (T4) kit
Version or Model: B065-01C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B065-01C
Company Name: Wallac Oy

Primary DI Number: 06438147179602
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.

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?
59222	Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroxine (neonatal T4) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDX	Radioimmunoassay, Total Thyroxine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e501187-afc5-48cc-9d86-af8c38b6b2b3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 02, 2016