Duns Number:045623154
Device Description: Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 10ml R2. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Catalog Number
14-L7572-200
Brand Name
Pointe Lactate Dehydrogenase Reagent
Version/Model Number
14-L7572-200
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
K973589
Product Code
CFJ
Product Code Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Public Device Record Key
c8078b97-d3ac-4b87-9315-eb4f837a2be5
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 2021
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |