NanoEnTek, Inc.

Address:851-14, Seohae-ro, Paltan-myeon,Hwaseong Gyeonggi,KR

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- Catalog Number : FRT4AP 020

Device Description : It is used for the quantitative determination of free thyroxine(free t4) in huma It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : CEC

Prescription Use : Yes

Device Count : 1

- Catalog Number : F10AP

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : JRG

Prescription Use : Yes

Device Count : 1

- Catalog Number : FRPS 025

Device Description : It is used for the quantitiative determination of Prostate Specific Antigen(PSA) It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : ADAM-rWBC2 device

Device Description : ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : ADAM-rWBC2

Device Description : ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent) ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in the human specimen.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : DHC-N01

Device Description : The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-N01 grid pattern is exactly same as the Neubauer Improved. 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 (Fig. 1). The central square is divided into 25 small squares with triple lines and four corner squares are divided into 16 small squares.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : GHO

Prescription Use : Yes

Device Count : 1

- Catalog Number : FLK-FT4

Device Description : FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity materia FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

- Catalog Number : FLK-PSA

Device Description : FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity materi FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only.FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

- Catalog Number : FLK-TES

Device Description : FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity ma FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Testosterone Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

- Catalog Number : FLK-TSH

Device Description : FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1