Nano-CheckTM Dengue IgM/IgG MD8144

GUDID 00895160002489

Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00895160002489
NIH Device Record Key	0d035370-f1f9-4068-a47d-408c95a2e492
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nano-CheckTM Dengue IgM/IgG
Version Model Number	MD8144
Catalog Number	MD8144
Company DUNS	126544316
Company Name	NANO-DITECH CORPORATION
Device Count	20
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00895160002489 [Primary]
GS1	10895160002486 [Unit of Use]

NWY	Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

Steralize Prior To Use	false
Device Is Sterile	false

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