Duns Number:840839190
Device Description: 15mL/bottle.Concentration of Multi-Analyte: 375 ng/mL MDMA, 1500 ng/mL morphine, 150 ng/mL 15mL/bottle.Concentration of Multi-Analyte: 375 ng/mL MDMA, 1500 ng/mL morphine, 150 ng/mL oxazepam, and 150 ng/mL secobarbital.
Catalog Number
0837
Brand Name
Multi-Analyte DAU Control Set B, Level 1 Control
Version/Model Number
0837
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
K133710
Product Code
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
d1e9d407-1aa0-4c9b-bc7c-5b0d37789b0c
Public Version Date
August 24, 2018
Public Version Number
4
DI Record Publish Date
July 05, 2016
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 |