Duns Number:362917692
Device Description: Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister)
Catalog Number
BSP-185-50-01
Brand Name
Status Strep A Plus
Version/Model Number
BSP-185-50-01
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)
-
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
6140d7a2-96a9-4aa7-91c2-2071f69aaf63
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 23, 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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |
| U | Unclassified | 2 |