MedTest DX Phosphorus Reagent for the BS480 - For the quantitative determination of Inorganic - Medtest Dx, Inc.

Duns Number:070371210

Device Description: For the quantitative determination of Inorganic Phosphorus in serum using the Mindray BS-4 For the quantitative determination of Inorganic Phosphorus in serum using the Mindray BS-480 analyzer.3 x 58 ml.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

PHO480

Brand Name

MedTest DX Phosphorus Reagent for the BS480

Version/Model Number

PHO480

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K822470

Product Code Details

Product Code

CEO

Product Code Name

Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Device Record Status

Public Device Record Key

621f92c2-2ffb-4408-abf1-4a46f8e0a787

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEST DX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 33