Nano-CheckTM Malaria MD8142

GUDID 00895160002465

Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00895160002465
NIH Device Record Key	f5953fe3-1650-49b3-a125-8fa1d574a780
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nano-CheckTM Malaria
Version Model Number	MD8142
Catalog Number	MD8142
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	00895160002465 [Primary]
GS1	10895160002462 [Unit of Use]

OAX	Plasmodium Spp. Detection Reagents

Steralize Prior To Use	false
Device Is Sterile	false

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