Medtest Dx, Inc.

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Device Description : Gamma glutamyl transferase Reagent is for the quantitative kinetic determination Gamma glutamyl transferase Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Hitachi analyzers. For in vitro diagnostic use only. 1 x 1L, 1 x 400ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JQB

Prescription Use : Yes

Device Count : 1

Device Description : This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems.6 x 3 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Device Description : This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems.6 x 3 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Device Description : This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Device Description : This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 03W500

Device Description : For use as a cleaning solution on automated analyzers. 6 x 25 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : Yes

Device Count : 1

- Catalog Number : 09W500

Device Description : For use as a cleaning solution on automated analyzers. 6 x 25 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : Yes

Device Count : 1

- Catalog Number : 10W500

Device Description : This product will be used as a concentrated wash solution on automated analyzers This product will be used as a concentrated wash solution on automated analyzers. 6 x 25 ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : Yes

Device Count : 1

- Catalog Number : ALB480

Device Description : For the quantitative determination of Albumin in serum using the Mindray BS-480 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.8 x 60 ml

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

- Catalog Number : ALB505

Device Description : For the quantitative in vitro determination of Albumin in serum and plasma on th For the quantitative in vitro determination of Albumin in serum and plasma on the Polychem 180 analyzer. 9 x 51 ml

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1