Duns Number:122561087
Device Description: BD Macro-Vue™ RPR Card Test Contents: Five 3 mL ampules RPR Card Antigen, 50 cards with 15 BD Macro-Vue™ RPR Card Test Contents: Five 3 mL ampules RPR Card Antigen, 50 cards with 15 18-mm circles, 150-0.05 mL capillaries, test disposables and accessories
Catalog Number
275239
Brand Name
BD Macro-Vue™ RPR Card Test
Version/Model Number
275239
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)
-
FDA Premarket Submission
-
Product Code
GMQ
Product Code Name
ANTIGENS, NONTREPONEMAL, ALL
Public Device Record Key
23d53470-f08a-4301-86e9-040248630cb4
Public Version Date
March 29, 2018
Public Version Number
2
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 |