Duns Number:840839190
Device Description: Large Test KitAntibody/Substrate Reagent (R1): 1000 mLEnzyme Conjugate Reagent (R2): 375 m Large Test KitAntibody/Substrate Reagent (R1): 1000 mLEnzyme Conjugate Reagent (R2): 375 mL
Catalog Number
0631
Brand Name
LZI Methadone II Enzyme Immunoassay
Version/Model Number
0631
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
3f3cc2af-0a14-4961-9f69-32f030f2bae5
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 |