Duns Number:137825928
Device Description: Radioimmunoassay for the quantitative determination of Vitamin B12 and Folate in human pla Radioimmunoassay for the quantitative determination of Vitamin B12 and Folate in human plasma or serum.
Catalog Number
06B264806
Brand Name
SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit
Version/Model Number
06B264806
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
Yes
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
K822728
Product Code
CGN
Product Code Name
ACID, FOLIC, RADIOIMMUNOASSAY
Public Device Record Key
6dcc4288-8404-482a-adf8-1f881f00d3f2
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
January 09, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |