Duns Number:083155515
Catalog Number
3425-300B
Brand Name
Monobind AccuBind NTSH ELISA Kit - 192 Wells
Version/Model Number
3425-300
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063437
Product Code
JLW
Product Code Name
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Public Device Record Key
ff41eebd-11af-4de9-83cf-8968ea24311e
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 11, 2019
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 | 94 |
2 | A medical device with a moderate to high risk that requires special controls. | 204 |