QuantStudio Dx Emerging Pathogens Edition Software Version 1.0.1

GUDID 10190302006736

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Laboratory instrument/analyser application software IVD
Primary Device ID10190302006736
NIH Device Record Key99aca19c-4368-4d9d-a2d6-562996326d8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantStudio Dx Emerging Pathogens Edition Software Version 1.0.1
Version Model Number1.0.1
Company DUNS628548377
Company NameLIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110190302006736 [Primary]

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-11
Device Publish Date2019-07-03

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