DS-33 GeneScan™ Install Kit - Dx

GUDID 10190302014052

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, control
Primary Device ID10190302014052
NIH Device Record Keyfb5bdb11-d905-4f08-b3b1-911398609c30
Commercial Distribution StatusIn Commercial Distribution
Brand NameDS-33 GeneScan™ Install Kit - Dx
Version Model Number4482975
Company DUNS790376607
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110190302014052 [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 Date2020-04-23
Device Publish Date2020-04-15

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