AccessGUDID - DEVICE: AutoDELFIA Unconjugated Estriol (uE3) kit (06438147119332)

GUDID

Device Identifier (DI) Information

Brand Name: AutoDELFIA Unconjugated Estriol (uE3) kit
Version or Model: B083-212
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B083-212
Company Name: Wallac Oy

Primary DI Number: 06438147119332
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).

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?
62124	Free estriol (oestriol) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a fluorescent immunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGI	Radioimmunoassay, Estriol

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: 295040f8-7f88-42e7-bb83-8f6ac04d051a
Public Version Date: December 18, 2018
Public Version Number: 3
DI Record Publish Date: June 01, 2016