NanoEnTek, Inc.

Address:12F, 5, Digital-ro 26-gil,Seoul,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hemocytometer (GHO) (3) Counter, Differential Cell (GKZ) (2) Reagent, Coronavirus Serological (QKO) (2) General Purpose Reagent (PPM) (1) Test, Residual, Wbc In Leukoreduced Blood (MZG) (1)

Premarket Exempt

No Yes

Clear

C-Chip - 08809317540696 Catalog Number : DHC-B0420

Device Description : The DHC-B0420 grid pattern is exactly same as the Burker. It consists of 9 large The DHC-B0420 grid pattern is exactly same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : GHO

Prescription Use : Yes

Device Count : 1

C-Chip - 08809317540702 Catalog Number : DHC-F04

Device Description : The DHC-F04 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists The DHC-F04 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : GHO

Prescription Use : Yes

Device Count : 1

C-Chip - 08809317540719 Catalog Number : DHC-F0420

Device Description : The DHC-F0420 grid pattern is exactly the same as the Fuchs-Rosenthal. It consis The DHC-F0420 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : GHO

Prescription Use : Yes

Device Count : 1

FREND - 08809317540825 Catalog Number : FRBR 015

Device Description : FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

FREND - 08809317540917 Catalog Number : FIC-COALQ

Device Description : The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COV The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.

Device Class :

Duns Number: 687910463

Premarket Exempt : No

Product Code : QKO

Prescription Use : Yes

Device Count : 1

FREND - 08809317540924 Catalog Number : FRCOA 020

Device Description : The COVID-19 total Ab is designed for the qualitative and quantitative measureme The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA,and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.

Device Class :

Duns Number: 687910463

Premarket Exempt : No

Product Code : QKO

Prescription Use : Yes

Device Count : 1

ADAM - 08809317540993 Catalog Number :

Device Description : The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

ADAM - 08809317541006 Catalog Number : ADHK-050

Device Description : It is used for the quantitative determination of the residual white blood cell ( It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

r-Control RBC and PLT - 08809317541143 Catalog Number : ADRC 020

Device Description : The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High proces The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High process controls and platelet (PLT) Low & PLT High process controls. It is intended for use with ADAM-rWBC Kit to monitor the process for enumeration of residual leukocytes in leukocyte reduced RBC and PLT products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : MZG

Prescription Use : Yes

Device Count : 1

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