Duns Number:840839190
Device Description: Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL.
Catalog Number
0311
Brand Name
Fentanyl Enzyme Immunoassay
Version/Model Number
0311
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K181159
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
9761f401-8ff9-4afb-a980-932975b6c883
Public Version Date
April 03, 2019
Public Version Number
1
DI Record Publish Date
March 26, 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 | 104 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |
| U | Unclassified | 2 |