96 WELL Retainer & Base STD CE-IVD

GUDID 10190302000253

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, reagent
Primary Device ID10190302000253
NIH Device Record Key58208497-4433-4dcb-b920-7450ad1a74bc
Commercial Distribution StatusIn Commercial Distribution
Brand Name96 WELL Retainer & Base STD CE-IVD
Version Model Number4410227
Company DUNS182158873
Company NameLIFE TECHNOLOGIES CORPORATION
Device Count4
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS110190302000253 [Primary]
GS180190302000252 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCADNA genetic analyzer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-23
Device Publish Date2016-08-01

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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