Duns Number:296822794
Device Description: Sycamore -Specific IgE - IMMULITE - RGT
Catalog Number
T11L2
Brand Name
IMMULITE®2000 Systems 3gAllergy™ Sycamore
Version/Model Number
10386057
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
9221e138-2113-4bde-bade-8d9bc1475c75
Public Version Date
June 10, 2022
Public Version Number
6
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 |