QuantStudio Dx Software V1.0.3, Kit

GUDID 10190302006729

LIFE TECHNOLOGIES CORPORATION

Laboratory instrument/analyser application software IVD
Primary Device ID10190302006729
NIH Device Record Key2395d344-bfe8-41fd-ab95-987e117c666b
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantStudio Dx Software V1.0.3, Kit
Version Model Number1.0.3
Company DUNS080131636
Company NameLIFE TECHNOLOGIES CORPORATION
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 Numberfalse
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
GS110190302006729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-04-15
Device Publish Date2018-07-13

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

10190302005197 - Aim -V™ Medium2024-06-04 AIM V MED
10190302012041 - Human CD99 FITC Conjugate2024-06-04 HU CD99 3B2/TA8 FITC MAB
10190302012058 - Human CD99 R-PE Conjugate2024-06-04 HU CD99 3B2/TA8 PE MAB
10190302012065 - Human CXCR4 (CD184) R-PE Conjugate2024-06-04 HU CXCR4 12G5 PE MAB
10190302012164 - Anti-Human HLA-DR (Class II) FITC Conjugate2024-06-04 HU HLA-DR TU36 FITC MAB
10190302012171 - Anti-Human HLA-DR (Class II) R-PE Conjugate2024-06-04 HU HLA-DR TU36 PE MAB
10190302012188 - Anti-Human HLA-DR (Class II) APC Conjugate2024-06-04 HU HLA-DR TU36 APC MAB
10190302012195 - Anti-Human HLA-DR (Class II) PE-Texas Red® Conjugate2024-06-04 HU HLA-DR TU36 PE-TX RED MAB

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