SAE Admin Console Dx Software V1.0 Kit

GUDID 10190302015554

LIFE TECHNOLOGIES CORPORATION

Laboratory instrument/analyser application software IVD
Primary Device ID10190302015554
NIH Device Record Key7295a843-adbe-45cd-91d0-de3bc89e36f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAE Admin Console Dx Software V1.0 Kit
Version Model NumberA48166, V1.0.0
Company DUNS080131636
Company NameLIFE TECHNOLOGIES CORPORATION
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 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
GS110190302015554 [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 Date2021-02-09
Device Publish Date2021-02-01

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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