RAPID TEST FOR P. FALCIPARUM MALARIA - India CDSCO Medical Device Registration

RAPID TEST FOR P. FALCIPARUM MALARIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000118_dae11344f9bb752953f267afd6827066_8774112d39ccb6f29963d4e600a7d3c1. This device is marketed under the brand name PARACHECK PF DEVICE. The license holder is ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Goa.

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CDSCO Registered

Class Class C

RAPID TEST FOR P. FALCIPARUM MALARIA

UID: MFG/IVD/2020/000118_dae11344f9bb752953f267afd6827066_8774112d39ccb6f29963d4e600a7d3c1

Brand Name

PARACHECK PF DEVICE

License Holder

ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Goa

Product Information

Paracheck Pf is a rapid self performing, qualitative, two site sandwich immunoassay for the determination of P. falciparum specific histidine rich protein –2 (PARACHECK PF DEVICE) in whole blood samples. Paracheck Pf detects the presence of Pf HRP-2 in whole blood specimen and is a sensitive and specific test for the detection of P. falciparum malaria.

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RAPID TEST FOR P. FALCIPARUM MALARIA

Brand: PARACHECK PF DEVICE

ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED

Class C

Brand: DEVICE

Class B