Duns Number:322209263
Catalog Number
-
Brand Name
IFA 40: HEp-20-10 EUROPattern
Version/Model Number
FC 1522-12010-1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DHN
Product Code Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
bf62c73c-a612-4040-8056-2c7471a47561
Public Version Date
June 18, 2018
Public Version Number
1
DI Record Publish Date
May 17, 2018
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 | 115 |
2 | A medical device with a moderate to high risk that requires special controls. | 213 |