Home GUDID 06438147331802 EnLite Neonatal TREC kit
Primary DI 06438147331802
Brand EnLite Neonatal TREC kit
Company Wallac Oy
Model 3401-001U
Catalog number 3401-001U
Device description Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.
Published 2016-02-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06438147331802 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06438147331802 06438147331802 6438147331802
GMDN Terms# Term, Definition table Term Definition 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).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -30 Degrees Celsius -16 Degrees Celsius
Regulatory Flags# DUNS number 540156544 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes#