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

Acid, Uric, Uricase (Colorimetric) (KNK) (1) Analyzer, Chemistry, Micro, For Clinical Use (JJF) (1)

Premarket Exempt

No Yes

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MedTest DX Uric Acid for the BS200 - 00817439021366 Catalog Number : UA600

Device Description : For the quantitative determination of Uric Acid in serum using the Mindray BS-20 For the quantitative determination of Uric Acid in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only. 3 x 40ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : KNK

Prescription Use : Yes

Device Count : 1

MedTest DX Wash Solution for the BS200 - 00817439021373 Catalog Number : WS600

Device Description : MedTest DX BS200 Wash Solution is packaged for use with the Mindray BS200 Analyz MedTest DX BS200 Wash Solution is packaged for use with the Mindray BS200 Analyzer and intended for cleaning after reagent testing. 4 x 40ml.

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : No

Device Count : 1

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