D-DIMER TURBILATEX - India CDSCO Medical Device Registration

D-DIMER TURBILATEX is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000055_2982fdeac9ebee280c613a752f8334ec_2f61a30712317a1bb31d1ecaa1b7ab6e. This device is marketed under the brand name RAPHA SERO. The license holder is M/s Rapha Diagnostics PVt. Ltd.,, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

D-DIMER TURBILATEX

UID: MFG/IVD/2021/000055_2982fdeac9ebee280c613a752f8334ec_2f61a30712317a1bb31d1ecaa1b7ab6e

Brand Name

RAPHA SERO

License Holder

M/s Rapha Diagnostics PVt. Ltd.,

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

SECURE D-Dimer is the diagnostic reagent for quantitative in vitro determination of D-dimer in Plasma on photometric systems. This product is used for in vitro diagnosis by professionals.