HbA1 c net FS - India CDSCO Medical Device Registration

HbA1 c net FS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000379_c1cbd60c938606c373832ba48be43b96_04cd935efece5034bcb074accfb179cb. This device is marketed under the brand name Bilirubin Auto Total FS. The license holder is Sysmex 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

HbA1 c net FS

UID: IMP/IVD/2019/000379_c1cbd60c938606c373832ba48be43b96_04cd935efece5034bcb074accfb179cb

Brand Name

Bilirubin Auto Total FS

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diagnostic reagent for quantitative in vitro determination of hemoglobin A1c in human whole blood, collected with EDTA, on automated Sysmex BX-3010

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LDL-C Select FS--Diagnostic reagent for quantitative in vitro determination of low density lipoprotein cholesterol in serum or plasma on Sysmex BX-Series.

Brand: Bilirubin Auto Total FS

Sysmex India Pvt. Ltd.

HbA1 c net FS - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

LDL-C Select FS--Diagnostic reagent for quantitative in vitro determination of low density lipoprotein cholesterol in serum or plasma on Sysmex BX-Series.

Cholesterol FS--Diagnostic reagent for quantitative in vitro determination of cholesterol in serum or plasma on Sysmex BX-Series.

Pancreatic Amylase CC FS--Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on Sysmex BX-Series.

Phosphate FS--Diagnostic reagent for quantitative in vitro determination of phosphorus in serum or plasma on Sysmex BX-Series.

TruLab HbA1 c net Level 1, TruLab HbA1 c net Level 2

LDL-c direct FS

CK-MB FS--Diagnostic reagent for quantitative in vitro determination of CK-MB in serum or plasma on Sysmex BX-Series.

Urea FS--Diagnostic reagent for quantitative in vitro determination of urea in serum, plasma or urine on Sysmex BX-Series.

Bilirubin Auto Total FS--Diagnostic reagent for quantitative in vitro determination of total bilirubin in serum or plasma on Sysmex BX-Series.

Calcium P FS--Diagnostic reagent for quantitative in vitro determination of calcium in serum or plasma on Sysmex BX-Series.

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner