Duns Number:619834542
Device Description: INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determinatio
Catalog Number
035-001
Brand Name
REAADS Protein C Test Kit
Version/Model Number
035-001
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
K972342
Product Code
GGP
Product Code Name
Test, Qualitative And Quantitative Factor Deficiency
Public Device Record Key
d1ecd4f4-d7c7-4189-bbd9-f620e635751d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 26, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |