Duns Number:227530649
Device Description: This product is intended for in vitro diagnostic use in the calibration of RF on clinical This product is intended for in vitro diagnostic use in the calibration of RF on clinical chemistry analysers.
Catalog Number
RF2301
Brand Name
RF CAL
Version/Model Number
RF2301
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
K972220
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
e5f4984e-e9ce-462c-b674-f7dcee6c553d
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |