96-Well 0.2-mL Calibration Plate 3 (TAMRA, NED, and Cy 5 dyes)

GUDID 10190302003353

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Optical instrument calibration/verification solution IVD
Primary Device ID10190302003353
NIH Device Record Keyf02b6769-90f2-4fb1-b9a5-fb62909a931a
Commercial Distribution StatusIn Commercial Distribution
Brand Name96-Well 0.2-mL Calibration Plate 3 (TAMRA, NED, and Cy 5 dyes)
Version Model NumberA31909
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
GS110190302003353 [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 Date2021-02-12
Device Publish Date2021-02-04

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

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
10190302019248 - KingFisher™ Apex Dx 96 PCR Head2023-08-11
10190302019255 - KingFisher™ Apex Dx 96 Combi Head2023-08-11
10190302019262 - KingFisher™ Apex Dx 96 Deep Well Head2023-08-11
10190302019279 - KingFisher™ Apex Dx 24 Combi Head2023-08-11
10190302019408 - Diomni™ Software, Version 4.0.02023-07-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.