Duns Number:070371210
Device Description: MedTest DX BS200 Wash Solution is packaged for use with the Mindray BS200 Analyzer and int MedTest DX BS200 Wash Solution is packaged for use with the Mindray BS200 Analyzer and intended for cleaning after reagent testing. 4 x 40ml.
Catalog Number
WS600
Brand Name
MedTest DX Wash Solution for the BS200
Version/Model Number
WS600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJF
Product Code Name
Analyzer, Chemistry, Micro, For Clinical Use
Public Device Record Key
ad921612-7297-4c2c-b351-333a49fdcaed
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |