Duns Number:068288943
Device Description: Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determinati Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum.Kit Contains:5 ml RF Latex Reagent10 ml Glycine-Saline Buffer Concentrate1 ml RF Positive Control1 ml RF Negative Control6-ring slideProduct Instructions
Catalog Number
R-20
Brand Name
RF LATEX Test Kit
Version/Model Number
R-20
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
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
-
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
051f80f2-f7ab-49e1-99c6-c4d1bba0750a
Public Version Date
June 04, 2021
Public Version Number
1
DI Record Publish Date
May 27, 2021
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. | 6 |