Duns Number:045361136
Device Description: Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Rheumatoid Factor in non-diluted serum.
Catalog Number
1155-100
Brand Name
RaPET® RF
Version/Model Number
1155-100
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
-
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
3ab51a2e-811e-4cb2-a3ab-d892066ef6f8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |