EnLite Neonatal TREC kit 3401-001U

GUDID 06438147331802

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

Wallac Oy

T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT)
Primary Device ID06438147331802
NIH Device Record Key558bfbeb-a479-41e4-a083-bc08323f596a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnLite Neonatal TREC kit
Version Model Number3401-001U
Catalog Number3401-001U
Company DUNS540156544
Company NameWallac Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147331802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-02-02

On-Brand Devices [EnLite Neonatal TREC kit]

06438147331826Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dr
06438147331819Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dr
06438147331802Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dr

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