Duns Number:840839190
Device Description: HYD 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL)
Catalog Number
C68830
Brand Name
LZI Hydrocodone 300 Qualitative Calibrator
Version/Model Number
C68830
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DLJ
Product Code Name
Calibrators, Drug Specific
Public Device Record Key
9f4f8bbb-46d8-46b3-baff-6b616f9c3ff5
Public Version Date
April 27, 2021
Public Version Number
1
DI Record Publish Date
April 19, 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 |