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CDSCO UID MFG/IVD/2022/000029_faa14c37a081b127ddc63285bcd075ef_bff0bcba2e77ed2eedb01e48c4b54b90

Blood Spots Collection Card for New Born Screening

CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITEDDevice Class Class AIndia CDSCOBrand: HbChek Control Set
VerifiedCDSCO · official registry
Registration details
UID
MFG/IVD/2022/000029_faa14c37a081b127ddc63285bcd075ef_bff0bcba2e77ed2eedb01e48c4b54b90
Device class
Class A
Brand name
HbChek Control Set
License holder
CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Approving authority
Goa
Product information
The Bornsafe NBS 903 Blood Spots Collection Card is used for blood sample collection of neonates by heel prick technique. The spotted blood is allowed to air dry thoroughly at ambient temperature. This blood spot is further used to perform newborn screening tests
About this record

Blood Spots Collection Card for New Born Screening is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000029_faa14c37a081b127ddc63285bcd075ef_bff0bcba2e77ed2eedb01e48c4b54b90. This device is marketed under the brand name HbChek Control Set. The license holder is CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is Goa.

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