Duns Number:102113867
Device Description: KIT, Northwestern Inhalant
Catalog Number
84505
Brand Name
CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel
Version/Model Number
84505
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2021
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
K823593,K833885,K834526,K843694,K926420,K934524
Product Code
DHB
Product Code Name
SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
Public Device Record Key
2e2703e3-31ad-4ee1-b310-fd4f0a3eae01
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
August 19, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |