Duns Number:164880598
Device Description: ARK™ EDDP 300 Cutoff Calibrator is intended for use in calibration of the ARK EDDP Assay.
Catalog Number
5051-0002-03
Brand Name
ARK™ EDDP 300 Cutoff Calibrator
Version/Model Number
5051-0002-03
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
K182779
Product Code
DLJ
Product Code Name
Calibrators, Drug Specific
Public Device Record Key
6a574597-cf04-4cfd-959a-abb1da05b16f
Public Version Date
February 21, 2019
Public Version Number
1
DI Record Publish Date
January 21, 2019
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| U | Unclassified | 4 |