Duns Number:064608573
Device Description: Atellica CH Methadone Metabolite (EDDP) (MetMtb)
Catalog Number
11097527
Brand Name
Atellica CH MetMtb
Version/Model Number
11097527
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 26, 2022
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
K023617
Product Code
DJR
Product Code Name
Enzyme immunoassay, methadone
Public Device Record Key
e1d85ed7-aba5-4ada-9a22-d06aa6cdfff2
Public Version Date
August 04, 2022
Public Version Number
6
DI Record Publish Date
December 22, 2017
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 |