Duns Number:024824641
Catalog Number
NUC-1042
Brand Name
ANA Nucleolar Control
Version/Model Number
NUC-1042
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K872845
Product Code
DHN
Product Code Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
56755b2c-da3a-4250-baf2-a5deadadc5b3
Public Version Date
March 04, 2020
Public Version Number
4
DI Record Publish Date
September 12, 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 | 68 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |