7500 Fast Dx Real-Time PCR  Instrument

GUDID 10190302000222

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated
Primary Device ID10190302000222
NIH Device Record Keye83f638d-1757-468a-8966-d7890f39bd40
Commercial Distribution StatusIn Commercial Distribution
Brand Name7500 Fast Dx Real-Time PCR  Instrument
Version Model Number7503
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 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
GS110190302000222 [Primary]

FDA Product Code

NSUInstrumentation for clinical multiplex test systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-07
Device Publish Date2016-08-01

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