Medtest Dx, Inc.

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Device Description : The Lipid Control set are assayed Lipid Controls produced from fresh human sera The Lipid Control set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens.6 x 3 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Device Description : Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calib Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a).1 x 20 ml, 1 x 10 ml

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

Device Description : The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determ The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples on the Mindray BS-480. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.4 x 40 ml, 4 x 14 ml

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : DFC

Prescription Use : Yes

Device Count : 1

Device Description : Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calib Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 ml.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

Device Description : Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calib Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 ml.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : DFC

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of magnesium in serum using the Mindray BS-48 For the quantitative determination of magnesium in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 12 x 20 ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of magnesium in serum using the Mindray BS-20 For the quantitative determination of magnesium in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination high-density lipoprotein cholesterol in human For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Polychem 180 analyzer. For in vitro diagnostic use only. 3 x 51 ml, 2 x 20 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of Inorganic Phosphorus in serum using the Mi For the quantitative determination of Inorganic Phosphorus in serum using the Mindray BS-480 analyzer.3 x 58 ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of Inorganic Phosphorus in serum using the Mi For the quantitative determination of Inorganic Phosphorus in serum using the Mindray BS-480 analyzer. 4 x 40 ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1