Duns Number:840839190
Device Description: 15mL/bottle.Concentration of Multi-Analyte: 250 ng/mL MDMA, 1000 ng/mL morphine, 100 ng/mL 15mL/bottle.Concentration of Multi-Analyte: 250 ng/mL MDMA, 1000 ng/mL morphine, 100 ng/mL oxazepam, and 100 ng/mL secobarbital.
Catalog Number
0832
Brand Name
Multi-Analyte DAU Calibrator Set B, Low Calibrator
Version/Model Number
0832
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
DKB
Product Code Name
Calibrators, Drug Mixture
Public Device Record Key
02a216f8-6be8-4ba8-bfe6-5757a0f03f78
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 |