Duns Number:460055742
Device Description: 3 x 3.0 ml RPR ANTIGEN1 x 1.5 ml REACTIVE CONTROL1 x 1.5 ml MODERATE REACTIVE CONTROL1 x 1 3 x 3.0 ml RPR ANTIGEN1 x 1.5 ml REACTIVE CONTROL1 x 1.5 ml MODERATE REACTIVE CONTROL1 x 1.5 ml NONREACTIVE CONTROL50 disposable cards500 dispensing / spreading pipettes1 antigen dispensing vial1 antigen dispensing needle
Catalog Number
-
Brand Name
Biokit RPR 500 TESTS
Version/Model Number
300625550
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
K910541
Product Code
GMQ
Product Code Name
Antigens, Nontreponemal, All
Public Device Record Key
0611d9ed-bdb6-4075-9add-61daa7150e28
Public Version Date
July 06, 2018
Public Version Number
3
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |