Duns Number:961027315
Device Description: SP RPR Carbon Antigen Merc Free 3ML
Catalog Number
B1077-64
Brand Name
CARDINAL HEALTH
Version/Model Number
B1077-64
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"
Yes
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
K851504,K851504
Product Code
GMP
Product Code Name
ANTISERA, CONTROL FOR NONTREPONEMAL TESTS
Public Device Record Key
1ed7e6f2-8743-47d1-befa-1778833bd59e
Public Version Date
July 19, 2018
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
20885380114417
Quantity per Package
3
Contains DI Package
10885380114410
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |