Human HLA-DR (Class II) Pacific Orange™ Conjugate

GUDID 10190302012225

HU HLA-DR TU36 PACORANGE MAB

LIFE TECHNOLOGIES CORPORATION

HLA class II antigen tissue typing IVD, antibody
Primary Device ID10190302012225
NIH Device Record Keyf574c353-00ec-4b6a-a173-0471449391ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuman HLA-DR (Class II) Pacific Orange™ Conjugate
Version Model NumberMHLDR30
Company DUNS080131636
Company NameLIFE TECHNOLOGIES CORPORATION
Device Count1
DM Exempttrue
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
GS110190302012225 [Primary]

FDA Product Code

MVUReagents, specific, analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-06-04
Device Publish Date2018-06-15

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

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10190302019002 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control2025-02-25 Component 3 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
10190302019019 - TaqPath™ 1-Step Select Master Mix (No ROX)2025-02-25 Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
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10190302019033 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control2025-02-25 Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
10190302019040 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control2025-02-25 Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
10190302019057 - TaqPath™ 1-Step Select Master Mix (No ROX)2025-02-25 Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)

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