Duns Number:227530649
Device Description: The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic t The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or plasma.
Catalog Number
LD2812
Brand Name
LDH
Version/Model Number
LD2812
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
Yes
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
K970684
Product Code
CFJ
Product Code Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Public Device Record Key
d8327e6e-f462-44bc-b2c4-de0c680655fd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |