384-Well Normalization Plates with FAM/ROX and VIC/ROX Dyes

GUDID 10190302000406

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

PCR instrument calibrator kit IVD
Primary Device ID10190302000406
NIH Device Record Key2204d06c-9de1-442e-889c-8945cb7ff460
Commercial Distribution StatusIn Commercial Distribution
Brand Name384-Well Normalization Plates with FAM/ROX and VIC/ROX Dyes
Version Model Number4432620
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 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
GS110190302000406 [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 Date2023-02-16
Device Publish Date2023-02-08

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