AccessGUDID - DEVICE: EnLite Neonatal TREC kit (06438147331802)

GUDID

Device Identifier (DI) Information

Brand Name: EnLite Neonatal TREC kit
Version or Model: 3401-001U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3401-001U
Company Name: Wallac Oy

Primary DI Number: 06438147331802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.

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):	Yes
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?
59089	T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of T-cell receptor excision circles, or circular remnants of deoxyribonucleic acid (DNA) formed during normal T-cell development, in a clinical specimen using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJI	Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN140010	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 -30 and -16 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 558bfbeb-a479-41e4-a083-bc08323f596a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 02, 2016