Duns Number:840839190
Device Description: Small Test KitAntibody/Substrate Reagent (R1): 100 mLEnzyme Conjugate Reagent (R2): 37.5 m Small Test KitAntibody/Substrate Reagent (R1): 100 mLEnzyme Conjugate Reagent (R2): 37.5 mL
Catalog Number
0630
Brand Name
LZI Methadone II Enzyme Immunoassay
Version/Model Number
0630
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
K192433
Product Code
DJR
Product Code Name
Enzyme Immunoassay, Methadone
Public Device Record Key
b98852b6-4787-4863-8592-35d4f7746dce
Public Version Date
May 11, 2021
Public Version Number
1
DI Record Publish Date
May 03, 2021
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 |