PCR Ultra - India CDSCO Medical Device Registration

PCR Ultra is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000034_d1ae64eeb47563e583bd10419391d909_055f5a177bee7fea22df92ba525e45fa. This device is marketed under the brand name SPINREACT. The license holder is ARK DIAGNOSTICS BANGALORE PVT. LTD, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

PCR Ultra

UID: IMP/IVD/2020/000034_d1ae64eeb47563e583bd10419391d909_055f5a177bee7fea22df92ba525e45fa

Brand Name

SPINREACT

License Holder

ARK DIAGNOSTICS BANGALORE PVT. LTD

Device Class

Class B

Approving Authority

CDSCO

Product Information

Quantitative Determination of low levels of C-Reactive Protein in use of Vitro Diagnostics

DJ Fang

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ASO TURBI

Brand: SPINREACT

TRANSASIA BIO-MEDICALS LIMITED

PCR Ultra - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

ASO TURBI

RF TURBI

ASO TURBI CAL

CREATININE-TR Enzymatic

ASO/CRP/RF CONTROL low Level

RF TURBI CAL

ASO/CRP/RF CONTROL High Level

CREATININE –J

LIPASE –LQ

UREA –LQ

Lyse for blood cell analysis(LH Lyse- )

Diluent for Blood Cell Analysis(Diluent-)

Lyse for blood cell analysis(DIFF Lyse-)

Lyse for hemocyte analysis(Lyse Solution )

Diluent for hemocyte analysis(Diluent Solution)

Fully Auto HbA1c Analyzer(Fully Auto HbA1c Analyzer )

HbA1c Buffer

HbA1c Buffer

HbA1c Buffer

HbA1c Buffer