3500 Dx Series Data Collection Software 3 IVD Version 3.2

GUDID 10190302015066

LIFE TECHNOLOGIES CORPORATION

Laboratory instrument/analyser application software IVD
Primary Device ID10190302015066
NIH Device Record Key15577e88-15ce-443d-97c4-698d71c7e83b
Commercial Distribution StatusIn Commercial Distribution
Brand Name3500 Dx Series Data Collection Software 3 IVD Version 3.2
Version Model NumberA41856
Company DUNS080131636
Company NameLIFE TECHNOLOGIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS110190302015066 [Primary]

FDA Product Code

PCADNA genetic analyzer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-21
Device Publish Date2020-04-13

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

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10190302019033 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control2025-02-25 Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
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