Duns Number:013114656
Device Description: The AllergiEnd ST-9 Multiple skin Test Applicator has nine (9) test heads arranged in an a The AllergiEnd ST-9 Multiple skin Test Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9.
Catalog Number
1000
Brand Name
AllergiEnd ST-9
Version/Model Number
1000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2021
Issuing Agency
In HIBCC
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
K172062
Product Code
LDH
Product Code Name
System, Delivery, Allergen And Vaccine
Public Device Record Key
4463302c-8160-40ab-bd46-1289341d642f
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
November 30, 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 |
|---|---|---|
| U | Unclassified | 4 |