Duns Number:122561087
Device Description: BD BBL ™ Streptocard™ Enzyme Latex Kit Contains: Test Latex A,B,C,D,F and G (1 BD BBL ™ Streptocard™ Enzyme Latex Kit Contains: Test Latex A,B,C,D,F and G (1 x 2.5 mL), Extraction Enzyme (1 x 22 mL), Control + (1 x 2.5 Ml)
Catalog Number
240918
Brand Name
BD BBL™ Streptocard™ Enzyme Latex Kit
Version/Model Number
240918
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
GTZ
Product Code Name
ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
Public Device Record Key
074c006b-dec9-4ea0-9a7d-bb4b70bd60af
Public Version Date
June 25, 2018
Public Version Number
1
DI Record Publish Date
May 25, 2018
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 |