PCT Fast Test Kit - India CDSCO Medical Device Registration

PCT Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000403_fcf0028bd71d505b743e613a3051b357_d6fe2473b6017e70a2079d0d24f4c8c6. This device is marketed under the brand name Imumunofluorescence Assay. The license holder is M/s. Reckon Diagnostics Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

PCT Fast Test Kit

UID: IMP/IVD/2019/000403_fcf0028bd71d505b743e613a3051b357_d6fe2473b6017e70a2079d0d24f4c8c6

Brand Name

Imumunofluorescence Assay

License Holder

M/s. Reckon Diagnostics Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

PCT Fast Test Kit (Imumunofluorescence Assay) is intended for in vitro quantitative determination of Procalcitonin (Imumunofluorescence Assay) in serum, plasma or whole blood. The test is used as an aid in the assessment and evaluation of patients suspected of bacterial infection, trauma or shock.

Class B

CK-MB/cTnI/Myo Fast Test Kit

Brand: Imumunofluorescence Assay

Vector Biotek Pvt Ltd

Class C

Brand: CLIA

Class B