Duns Number:315786293
Device Description: ARCHITECT B.R.A.H.M.S PCT Reagent Kit
Catalog Number
06P2227
Brand Name
ARCHITECT
Version/Model Number
06P2227
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
K170652
Product Code
JIT
Product Code Name
Calibrator, secondary
Public Device Record Key
17388827-42f2-4cc4-9550-11aded47c671
Public Version Date
June 22, 2020
Public Version Number
4
DI Record Publish Date
August 16, 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 | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 185 |
| 3 | A medical device with high risk that requires premarket approval | 13 |