Duns Number:840839190
Device Description: EDDP 300 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 300 Low Calibrator 150 ng/mL (1 x 5 EDDP 300 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 300 Low Calibrator 150 ng/mL (1 x 5 mL), EDDP 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL), EDDP 300 Intermediate Calibrator 600 ng/mL (1 x 5 mL), EDDP 300 High Calibrator 1000 ng/mL (1 x 5 mL).
Catalog Number
08735662190
Brand Name
Methadone Metabolite 300 Semi-Quantitative Calibrators Set
Version/Model Number
08735662190
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
4d6b8392-f02b-4d7b-bb94-52c4f33779f9
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 |