Duns Number:251005005
Device Description: Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detec Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens.
Catalog Number
STR-15S25
Brand Name
Rapid Response
Version/Model Number
STR-15S25
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
K010582,K010582
Product Code
GTY
Product Code Name
Antigens, All Groups, Streptococcus Spp.
Public Device Record Key
64886e33-47e5-46e6-81ea-152122103230
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 25, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |