Duns Number:070371210
Device Description: Lactate, for the quantitative determination of lactate in human plasma on the Mindray BS-4 Lactate, for the quantitative determination of lactate in human plasma on the Mindray BS-480 Analyzer. For in vitro diagnostic use only. Size: 4 x 57 ml, 4 x 38 ml
Catalog Number
LAC480
Brand Name
MedTest DX Lactate
Version/Model Number
LAC480
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K961431
Product Code
CFJ
Product Code Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Public Device Record Key
247a9d0e-98e7-452a-9c2d-1b4f0d8a5d3f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 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 |