Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series) - India CDSCO Medical Device Registration

Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000130_f0a0657c02491b67427999a121a4a5ad_04c0973c8c71e6fd91de347d0ee50402. This device is marketed under the brand name serum Proteins Calibrator. The license holder is Labtech Health Care India 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

Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series)

UID: IMP/IVD/2022/000130_f0a0657c02491b67427999a121a4a5ad_04c0973c8c71e6fd91de347d0ee50402

Brand Name

serum Proteins Calibrator

License Holder

Labtech Health Care India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

This product is designed to be used on a Spinreact 5-Part-Diff haematology analyser along with Lyse and Sheath reagents produced by SPINREACT, for testing the cell content in human blood

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BILIRUBIN T&D –DMSO

Brand: serum Proteins Calibrator

Labtech Health Care India Pvt. Ltd.

Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

BILIRUBIN T&D –DMSO

CREATININE -J

Direct HbA1c

IgM (IgM )

Albumin

IgG (IgG )

Pre-albumin

Direct Bilirubin - DPD

Serum Proteins Calibrator

SPINCHEM 2 Human Control serum

HbA1c Calibrator

HbA1c Reagent Kit (HbA1c Reagent Kit )

HbA1c Analyzer(HbA1c Analyzer )

HbA1c Control Material

BILIRUBIN T&D –DMSO

CREATININE -J

Direct HbA1c

IgM (IgM )

Albumin

IgG (IgG )