Duns Number:806777541
Device Description: DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (5mL each); First Sign for DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (5mL each); First Sign for HemosureAMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OPI/OXY/PCP/TCA/THC
Catalog Number
D0115TC-01
Brand Name
FIRST SIGN®
Version/Model Number
D0115TC-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
Yes
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
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
501cce43-0337-4b53-b384-fff56e7cce32
Public Version Date
December 31, 2018
Public Version Number
3
DI Record Publish Date
September 21, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |