CDSCO UID MFG/IVD/2019/000025_fbba546823a1835a1b2a2aef88e71170_ed9fbdde54bdcbda4e35a31cf90a34c2

Rapid Test for P. falciparum Malaria - Dipstick

ARKRAY HEALTHCARE PVT. LTD.·Device Class Class C·India CDSCO·Brand: Crystal Dengue NS1
Registration details
UID
MFG/IVD/2019/000025_fbba546823a1835a1b2a2aef88e71170_ed9fbdde54bdcbda4e35a31cf90a34c2
Device class
Class C
Brand name
Crystal Dengue NS1
Approving authority
Central Drug Standards Control Organization, Ahmedabad
Product information
ParaHIT f Ver. 1.0 - Rapid Test for P. falciparum Malaria provides a simple, rapid and an in vitro qualitative screening test for the detection of Plasmodium falciparum specific HRP-II (Crystal Dengue NS1) in human blood. It does not require additional instrument. The assay is intended for use by Health Care Workers / Laboratory Professionals, only for an initial screening. The assay is to be used in the diagnosis of malaria in symptomatic patients. This test kit is standardized to withstand tropical conditions
Similar products (10)
Other products with the same name or brand
Immunochromatographic One Step Rapid Visual Test for Vibrio cholerae – Dipstick
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Rapid Test for P. falciparum and P. vivax Malaria - Device
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Rapid Test for P. falciparum and Pan Malarial Species-Device
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Rapid Test for P. falciparum and Pan Malarial Species-Device
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Blood Glucose Meter with Bluetooth
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Blood Glucose Test Meter
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Ellagic Acid Activated Reagent for Partial Thromboplastin Time
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Rapid Test for P. falciparum and Pan Malarial Species-Dipstick
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Brain Thromboplastin with Calcium Reagent for Prothrombin Time
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Immunochromatographic rapid visual test for detection of Dengue NS1 Antigen and Differential Anti-Dengue IgG and IgM antibodies in Human Serum, Plasma or Whole Blood – Device
Brand: Crystal Dengue NS1
ARKRAY HEALTHCARE PVT. LTD.
Class C
Other products from ARKRAY HEALTHCARE PVT. LTD.
Products from the same license holder (10 products)
Cefuroxime Sensitivity Disc , 30 µg/ Disc
Brand: AutoSpan Liquid Gold Lipase
Class B
Stained Salmonella Antigen Set : For Widal Test
Class B
Stained Salmonella Antigen Set : For Widal Test
Class B
Piperacillin / tazobactum Sensitivity Disc , 100 + 10 µg/ Disc
Brand: AutoSpan Liquid Gold Lipase
Class B
Amoxycillin / clavulanic acid Sensitivity Disc , 20+10 µg/ Disc
Brand: AutoSpan Liquid Gold Lipase
Class B
Co-Trimoxazole Sensitivity Disc , 25 µg/Disc
Brand: AutoSpan Liquid Gold Lipase
Class B
Sodium: Trinder's, Potassium : Tetraphenyl Boron, End Point Assay
Brand: AutoSpan Liquid Gold Lipase
Class B
Tetracycline Sensitivity Disc , 30 μg / Disc
Brand: AutoSpan Liquid Gold Lipase
Class B
Stained Salmonella S. typhi ‘H’ Antigen : For Widal test
Class B
Cefixime Sensitivity Disc , 5 µg/ Disc
Brand: AutoSpan Liquid Gold Lipase
Class B
About this record

Rapid Test for P. falciparum Malaria - Dipstick is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_fbba546823a1835a1b2a2aef88e71170_ed9fbdde54bdcbda4e35a31cf90a34c2. This device is marketed under the brand name Crystal Dengue NS1. The license holder is ARKRAY HEALTHCARE PVT. LTD., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.