384-Well Region of Interest and Background Plates

GUDID 10190302000314

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

PCR instrument calibrator kit IVD
Primary Device ID10190302000314
NIH Device Record Key09cd943e-2650-4651-8d4d-7edb7d6bb547
Commercial Distribution StatusIn Commercial Distribution
Brand Name384-Well Region of Interest and Background Plates
Version Model Number4432482
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
GS110190302000314 [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 Date2022-05-09
Device Publish Date2022-05-01

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

10190302019897 - Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, Fast2025-08-27 Applied Biosystems ABY Dye Spectral Calibration Plate for Multiplex qPCR used for ABY dye spectral calibration of the Applied Bi
10190302019903 - Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, Fast2025-08-27 Applied Biosystems JUN Dye Spectral Calibration Plate for Multiplex qPCR used for JUN dye spectral calibration of the Applied Bi
10190302018883 - Ion Torrent Genexus Dx Software2025-08-01 Ion Torrent Genexus Dx Software
10190302019859 - Diomni™ Software, Version 4.2.02025-05-12
10190302019958 - Torrent Suite DX SW, Installer V5.14.22025-02-27 Torrent Suite Dx SW, Installer V5.14.2
10190302007399 - Array Card Clip2024-06-04 VIIA 7 DX ARRAY CARD BUCKET
10190302019514 - Diomni™ Software, Version 4.1.02024-05-06
10190302019231 - KingFisher™ Apex Dx Purification Instrument2023-08-11

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.