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Nano-CheckTM Malaria

FDA UDI

Class II (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Nano-CheckTM Malaria FDA UDI
Generic Name
Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection. FDA UDI
Model / Reference
MD8142 FDA UDI
Description
An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection. FDA UDI

Identifiers

Catalog Number
MD8142 FDA UDI
Primary DI / UDI-DI
00895160002465 FDA UDI
FDA Product Code
OAX FDA UDI
GMDN Term
Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3402 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical

Nano-CheckTM Malaria by Nano-Ditech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nano-Ditech Corporation

Sources (1)

  • FDA UDI f5953fe3-1650-49b3-a125-8fa1d574a780 35 fields · synced Jun 9, 2026