Duns Number:079226220
Device Description: ARCHITECT STAT Myoglobin Reagent Kit
Catalog Number
02K4320
Brand Name
ARCHITECT
Version/Model Number
2K43-20
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
-
Product Code
DDR
Product Code Name
MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
81a7963f-6680-4c1d-bf80-726e703c1873
Public Version Date
March 29, 2018
Public Version Number
2
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 |