Duns Number:840839190
Device Description: EDDP 300 Negative Control 225 ng/mL (2 x 15 mL),EDDP 300 Positive Control 375 ng/mL (2 x 1 EDDP 300 Negative Control 225 ng/mL (2 x 15 mL),EDDP 300 Positive Control 375 ng/mL (2 x 15 mL).
Catalog Number
08735689190
Brand Name
Methadone Metabolite 300 Control Set
Version/Model Number
08735689190
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
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
b1d7d659-2e39-4491-abe8-00a6af55cfd7
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 16, 2019
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 |