3500 Dx Genetic Analyzer

GUDID 10190302005937

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Nucleic acid sequence analyser IVD, Sanger sequencing
Primary Device ID10190302005937
NIH Device Record Key725d397f-8a90-47f0-9d41-be2215d4bba0
Commercial Distribution StatusIn Commercial Distribution
Brand Name3500 Dx Genetic Analyzer
Version Model Number4405182
Company DUNS628548377
Company NameLIFE TECHNOLOGIES HOLDINGS PTE. LTD.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS110190302005937 [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 Date2020-05-04
Device Publish Date2020-04-24

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