Duns Number:079226220
Device Description: ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
Catalog Number
01L7555
Brand Name
ARCHITECT
Version/Model Number
1L75-55
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080751
Product Code
DLJ
Product Code Name
CALIBRATORS, DRUG SPECIFIC
Public Device Record Key
917f98f4-448c-4982-84a0-11423d0641f0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 06, 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 |