Duns Number:070371210
Device Description: Lactate Standard, intended for use as an Lactate standard for standardization or calibrati Lactate Standard, intended for use as an Lactate standard for standardization or calibration of Lactate Oxidase, Lactate procedures. Size: 1 x15 ml
Catalog Number
LACS480
Brand Name
MedTest DX Lactate Standard
Version/Model Number
LACS480
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
4fe5f657-0dd1-45a7-b5e6-56bae6ad13a4
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 |