Duns Number:012430880
Device Description: One Step+ Strep A Dipstick 25 Test
Catalog Number
1074050
Brand Name
Henry Schein
Version/Model Number
1074050
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
GTY
Product Code Name
ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
Public Device Record Key
dd9eca03-7636-4b57-8b37-cf8687815fb2
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20304040024144
Quantity per Package
40
Contains DI Package
10304040024147
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |