Duns Number:354019424
Device Description: EliA ANA Positive Control 100
Catalog Number
83-0006-91
Brand Name
EliA ANA Positive Control 100
Version/Model Number
83-0006-91
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
K072393,K072393
Product Code
JJY
Product Code Name
Multi-analyte controls, all kinds (assayed)
Public Device Record Key
896020d7-c584-4234-8d91-ea14a314984f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
07333066013879
Quantity per Package
6
Contains DI Package
07333066013046
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 225 |
2 | A medical device with a moderate to high risk that requires special controls. | 518 |