Duns Number:296822794
Device Description: Specific IgE D2 - IMMULITE - CTL - 1x4mL
Catalog Number
DC2LCM
Brand Name
IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2
Version/Model Number
10485105
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013134
Product Code
DHB
Product Code Name
SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
Public Device Record Key
3349131e-ac44-4145-8a85-abbb61ed11e7
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 24, 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 | 143 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 493 |
| 3 | A medical device with high risk that requires premarket approval | 22 |