Duns Number:079226220
Device Description: XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators
Catalog Number
07A1201
Brand Name
ABBOTT
Version/Model Number
7A12-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LAO
Product Code Name
Enzyme immunoassay, methotrexate
Public Device Record Key
a88c4e82-10be-4957-b942-d436459ac3d9
Public Version Date
June 26, 2019
Public Version Number
3
DI Record Publish Date
September 09, 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 | 259 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 245 |
| U | Unclassified | 5 |