Duns Number:122561087
Device Description: BD Macro-Vue™ RPR Card Test Liquid Controls
Catalog Number
276909
Brand Name
BD Macro-Vue™ RPR Card Test Liquid Controls
Version/Model Number
276909
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
K980638
Product Code
GMP
Product Code Name
ANTISERA, CONTROL FOR NONTREPONEMAL TESTS
Public Device Record Key
355842b4-8a9b-4571-b426-4eaeee56727c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 19, 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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |