Duns Number:064608573
Device Description: Free T4 (FT4) - Atellica IM - RGT 1250T
Catalog Number
11206313
Brand Name
Atellica IM FT4
Version/Model Number
11206313
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
-
Product Code
CEC
Product Code Name
RADIOIMMUNOASSAY, FREE THYROXINE
Public Device Record Key
ba2b78ed-d093-42fd-9b6b-7a9678b119cd
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
December 12, 2020
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |