Duns Number:840839190
Device Description: 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.1 mL.
Catalog Number
08240035190
Brand Name
6-Acetylmorphine Enzyme Immunoassay
Version/Model Number
08240035190
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
-
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
74e14468-b9ca-4d34-8a86-1d3b07a59156
Public Version Date
October 15, 2018
Public Version Number
5
DI Record Publish Date
April 20, 2018
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 |