Medtest Dx, Inc.

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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

Diazo Colorimetry, Bilirubin (CIG) (3) Biuret (Colorimetric), Total Protein (CEK) (2) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (2) Acid, Uric, Uricase (Colorimetric) (KNK) (1) Calibrator, Secondary (JIT) (1) Ferrozine (Colorimetric) Iron Binding Capacity (JMO) (1)

Premarket Exempt

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MedTest DX Total Bilirubin for the BS480 - 00817439021236 Catalog Number : TIB480

Device Description : For the quantitative determination of total bilirubin in serum using the Mindray For the quantitative determination of total bilirubin in serum using the Mindray BS480 analyzer. For in vitro diagnostic use only.5 x 58ml, 5 x 15ml.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Total Bilirubin for the Polychem 180 - 00817439021243 Catalog Number : TIB505

Device Description : For the quantitative determination of total bilirubin in serum using the Poly-Ch For the quantitative determination of total bilirubin in serum using the Poly-Chem 180 analyzer. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Total Bilirubin for the BS200 - 00817439021250 Catalog Number : TIB600

Device Description : For the quantitative determination of total bilirubin in serum using the Mindray For the quantitative determination of total bilirubin in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only.3 x 40ml, 3 x 8ml.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Direct TIBC Reagent - 00817439021267 Catalog Number : TIBC480

Device Description : For use in the determination of total iron-binding capacity in serum on the Mind For use in the determination of total iron-binding capacity in serum on the Mindray BS-480 analyzer. For in vitro diagnostic use only.4 x 60ml, 4 x 36ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JMO

Prescription Use : Yes

Device Count : 1

Direct TIBC Calibrators - 00817439021274 Catalog Number : TIBCC480

Device Description : For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. 2 x 1ml.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

MedTest DX Total Protein for the BS480 - 00817439021281 Catalog Number : TP480

Device Description : For the quantitative determination of total protein concentration in serum using For the quantitative determination of total protein concentration in serum using the Mindray BS-480 analyzer. 8 x 60ml.

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

MedTest DX Total Protein for the BS200 - 00817439021304 Catalog Number : TP600

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

MedTest DX Triglycerides for the BS480 - 00817439021311 Catalog Number : TRI480

Device Description : For the in vitro quantitative determination of Triglycerides in serum or plasma For the in vitro quantitative determination of Triglycerides in serum or plasma using the Mindray BS-480 analyzer. 8 x 60ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

MedTest DX Triglycerides for the BS200 - 00817439021335 Catalog Number : TRI600

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

MedTest DX Uric Acid for the BS480 - 00817439021342 Catalog Number : UA480

Device Description : For the quantitative determination of Uric Acid in serum using the Mindray BS-48 For the quantitative determination of Uric Acid in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 4 x 40ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : KNK

Prescription Use : Yes

Device Count : 1

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