Controls(e-CHECK L3) - India CDSCO Medical Device Registration

Controls(e-CHECK L3) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000162_ae752c5ae596ef64a29645dbd4d0d317_20548be86282de9d5cf010d673736ba8. This device is marketed under the brand name EIGHTCHECK-3WP-H. 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

Controls(e-CHECK L3)

UID: IMP/IVD/2019/000162_ae752c5ae596ef64a29645dbd4d0d317_20548be86282de9d5cf010d673736ba8

Brand Name

EIGHTCHECK-3WP-H

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

e-CHECK(EIGHTCHECK-3WP-H) is a hematology control material primarily for intralaboratory quality control of automated, semiautomated and manual procedures that measure components of the blood. Additionally, e-CHECK(EIGHTCHECK-3WP-H) can be used in external quality assessment. Do not use e-CHECK(EIGHTCHECK-3WP-H) to calibrate the instrument

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Controls(e-CHECK L2)

Brand: EIGHTCHECK-3WP-H

Sysmex India Pvt. Ltd.

Controls(e-CHECK L3) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Controls(e-CHECK L2)

Controls(e-CHECK L2)

Calibrator

Calibrator

Calibrator

Controls(e-Check L3)

Controls(e-CHECK L1)

Controls(e-CHECK L1)

Controls

Controls

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner