Duns Number:126544316
Device Description: An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) o 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.
Catalog Number
MD8142
Brand Name
Nano-CheckTM Malaria
Version/Model Number
MD8142
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OAX
Product Code Name
Plasmodium Spp. Detection Reagents
Public Device Record Key
f5953fe3-1650-49b3-a125-8fa1d574a780
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
May 04, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-