CDSCO UID IMP/IVD/2019/000379_d82351c0c86b02bc2b90690fa594e195_492dfd129a711d4d53e32970c31d4051

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

Sysmex India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: Bilirubin Auto Total FS
Registration details
UID
IMP/IVD/2019/000379_d82351c0c86b02bc2b90690fa594e195_492dfd129a711d4d53e32970c31d4051
Device class
Class B
Brand name
Bilirubin Auto Total FS
Approving authority
CDSCO
Product information
Assayed quality control material for monitoring assay performance of quantitative in vitro determination of hemoglobin A1c (Bilirubin Auto Total FS)
Similar products (10)
Other products with the same name or brand
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.
Class B
Cholesterol FS--Diagnostic reagent for quantitative in vitro determination of cholesterol in serum or plasma on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
Pancreatic Amylase CC FS--Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
Phosphate FS--Diagnostic reagent for quantitative in vitro determination of phosphorus in serum or plasma on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
LDL-c direct FS
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
CK-MB FS--Diagnostic reagent for quantitative in vitro determination of CK-MB in serum or plasma on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
HbA1 c net FS
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
Urea FS--Diagnostic reagent for quantitative in vitro determination of urea in serum, plasma or urine on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
Bilirubin Auto Total FS--Diagnostic reagent for quantitative in vitro determination of total bilirubin in serum or plasma on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
Calcium P FS--Diagnostic reagent for quantitative in vitro determination of calcium in serum or plasma on Sysmex BX-Series.
Brand: Bilirubin Auto Total FS
Sysmex India Pvt. Ltd.
Class B
Other products from Sysmex India Pvt. Ltd.
Products from the same license holder (10 products)
Sheath Fluid
Brand: Sheath Fluid
Class B
Cl Electrode
Brand: Cl Electrode
Class B
Na Electrode
Brand: Cl Electrode
Class B
K Electrode
Brand: Cl Electrode
Class B
Diluent
Brand: H Solution
Class A
L Solution
Brand: H Solution
Class A
REF Solution
Brand: H Solution
Class A
Ref Electrode
Brand: Cl Electrode
Class B
H Solution
Brand: H Solution
Class A
ISE Cleaner
Brand: H Solution
Class A
About this record

TruLab HbA1 c net Level 1, TruLab HbA1 c net Level 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000379_d82351c0c86b02bc2b90690fa594e195_492dfd129a711d4d53e32970c31d4051. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.