Duns Number:961027315
Device Description: STREP A CASSETTE RAPID TEST
Catalog Number
B1077-40
Brand Name
CARDINAL HEALTH
Version/Model Number
B1077-40
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
-
Product Code
GTY
Product Code Name
ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
Public Device Record Key
fd83647d-84e1-4b54-8075-5cd08a81229c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 03, 2019
Package DI Number
50885380106956
Quantity per Package
15
Contains DI Package
20885380106955
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |