Duns Number:164880598
Device Description: The ARK™ Methotrexate Control consists of a three-level set used for quality control of th The ARK™ Methotrexate Control consists of a three-level set used for quality control of the assay (tri-level calibration range set). The controls consist of a synthetic protein matrix and the levels are 0.07 umol/L, 0.40 umol/L and 0.80umol/L.
Catalog Number
5026-0003-01
Brand Name
ARK™ Methotrexate Control
Version/Model Number
5026-0003-01
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
K111904
Product Code
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
19eebd58-b3c1-411d-9b7c-3f406c4fe6f7
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| U | Unclassified | 4 |