Test, Residual, WBC In Leukoreduced Blood
Nanoentek, Inc.
NANOENTEK AMERICA, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007113174 | 3007113174 | NANOENTEK AMERICA, INC | 1 | Y | 2026-01-01 | 220 Bear Hill Road Suite 102 North Waltham MA US 02451 |
| 3007349751 | 3007349751 | NANOENTEK INC | 1 | N | 2026-01-01 | 851-14, Seohae-ro, Paltan-myeon Hwaseong Gyeonggi KR 18531 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 190925 | 1595159786 | K162754 | FREND Vitamin D Test System | MRG | 2017-01-12 |
| 190925 | 1376110387 | K162378 | FREND PSA PLUS (reagent cartridge) | LTJ | 2017-05-17 |
| 190925 | 1441399359 | K153577 | FREND Testosterone Test System | CDZ | 2016-10-14 |
| 190925 | 1063264547 | K152422 | FREND™ Free T4 Test System | CEC | 2016-02-17 |
| 190925 | 2010418303 | K131928 | FREND TSH (REAGENT CARTRIDGE) | JLW | 2014-03-14 |
| 190925 | 2004507500 | K124056 | FREND PSA PLUS (REAGENT CARTRIDGE) | LTJ | 2013-05-29 |
| 190925 | 1538248407 | K053452 | PURE-AID PREGNANCY TEST | LCX | 2006-05-25 |
| 190925 | 1232706589 | BK231031 | |||
| 190925 | 1752018513 | BK210621 | |||
| 190925 | 1688958343 | BK200525 | |||
| 190925 | 1445010298 | BK180283 | |||
| 190925 | 1906043644 | BK120068 | |||
| 190925 | 1263774033 | BK120015 | |||
| 190925 | 1717863790 | ||||
| 149845 | 1155854415 | ||||
| 190925 | 1155854415 | ||||
| 149845 | 1180020665 | ||||
| 190925 | 1180020665 | ||||
| 190925 | 1285180323 | ||||
| 190925 | 1487549922 | ||||
| 149845 | 1487549922 | ||||
| 190925 | 1496618193 | ||||
| 190925 | 1516818256 | ||||
| 190925 | 1720265085 | ||||
| 190925 | 1758011481 | ||||
| 149845 | 1967812997 | ||||
| 190925 | 1967812997 | ||||
| 190925 | 2056061178 | ||||
| 149845 | 2056061178 |
Product Codes Associated With Registrations#
PMN#
Automated Differential Cell Counter
Nanoentek, Inc.
FREND PSA PLUS (reagent Cartridge)
NANOENTEK USA INC
FREND Vitamin D Test System
NanoEnTek USA, Inc.
FREND Testosterone Test System
NanoEnTek USA Inc.
FREND™ Free T4 Test System
NANOENTEK USA INC
Automated Differential Cell Counter
Nanoentek, Inc.
Automated Differential Cell Counter
Nanoentek, Inc.
Automated Blood Grouping And Antibody Test Systems
Nanoentek, Inc.
GUDID#
FREND System - FREND System is designed for reding the FREND cartridge of a quantitative.
2024-06-30
ADAM-rWBC - ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
2018-06-11
ADAM-rWBC Kit - It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
2016-09-30
ADAM-rWBC System - ADAM-rWBC System is composted ADAM-rWBC(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 human specimen.
2016-09-30
ADAM-rWBC2 - ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
2018-06-19
ADAM-rWBC2 System - 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.
2018-06-19
FREND System - FREND System is designed for reding the FREND cartridge of a quantitative.
2018-05-04
FREND Testosterone - It is used for the quantitiative determination of Testosterone in human specimen using FREND System.
2016-11-28
FREND Testosterone - It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample.
2018-05-04
FREND AP - F10AP
2018-06-11
r-Control RBC and PLT - 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.
2021-12-08
ADAM-rWBC HT - The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products.
2021-02-15
ADAM-rWBC Kit - It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT.
2021-02-15
FREND Free T4 Linearity Kit - 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.
2018-10-01
FREND TSH Linearity Kit - 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.
2018-10-01
FREND Vitamin D Linearity Kit - 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.
2018-10-01
ADAMII - ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
2020-09-02
ADAMII-CD34 Kit - ADAMII-CD34 Kit provides enumeration of viable CD34+ cells, viable CD45+ cells, and calculates percentage of viable CD34+ cells out of viable CD45+ cells. ADAMII-CD34 Kit can be used for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, haematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin, fresh cord blood (FCB) collected in CPD, and thawed frozen cord blood (TFCB) collected in CPD and stored with 10% DMSO, 1% Dextran 40.
2020-09-02
COVID-19 total Ab Control LQ - 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.
2020-09-02
FREND COVID-19 total Ab - 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.
2020-09-02
FREND Blocking Reagent - 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.
2020-03-24
FREND TSH - It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
2016-09-30
FREND Free T4 - It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.
2016-09-30
FREND Vitamin D - It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma.
2017-01-27
FREND Free T4 - It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.
2018-05-04
FREND PSA Plus Linearity Kit - 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.
2018-10-01
FREND Testosterone Linearity Kit - 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
2018-10-01
FREND PSA Plus - It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.
2016-09-30
FREND PSA Plus - It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.
2018-05-04
C-Chip - 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-F01 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.
2018-10-01
C-Chip - The DHC-N04 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.
2019-06-25
C-Chip - The DHC-N0420 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.
2019-06-25
C-Chip - The DHC-B04 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.
2019-06-25
C-Chip - 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.
2019-06-25
C-Chip - 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.
2019-06-25
C-Chip - 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.
2019-06-25
C-Chip - 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.
2018-10-01
C-Chip - 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-B01 grid pattern is exactly the 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.The large squares are subdivided into 16 group squares with 0.2 mm sides. The group squares correspond in size to the Neubauer grid but have no further subdivisions.
2018-10-01
C-Chip - 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-B02 grid pattern is exactly the same as the Burker-Turk. 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.The large squares are subdivided into 16 group squares with 0.2 mm sides. In the central large square, each group is subdivided into 16 mini squares with 0.05 mm sides (=0.0025 mm2).
2018-10-01
C-Chip - 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-M01 grid pattern is exactly same as the Malassez. It consists of 25 large squares, each measuring 0.2 x 0.25 mm and the depth of the chamber is 0.2 mm. Each square has a total volume of 0.01 mm3 or 10-5 cm3.The large squares are subdivided into 20 small squares with an area of 0.0025 mm2.Cells per mL = average count per large square x dilution factor x 105 (dilution factor)
2018-10-01