Nano-CheckTM Dengue NS1 MD8143

GUDID 00895160002472

An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.

NANO-DITECH CORPORATION

Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
Primary Device ID00895160002472
NIH Device Record Key5f849588-fdfb-478b-97b9-93c43b719c35
Commercial Distribution Discontinuation2022-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNano-CheckTM Dengue NS1
Version Model NumberMD8143
Catalog NumberMD8143
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002472 [Primary]
GS110895160002479 [Unit of Use]

FDA Product Code

OSUDengue Serological Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-29
Device Publish Date2017-11-08

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