Duns Number:005088112
Device Description: Syva® RapidTest d.a.u.® 8 THC / OPI / COC / mAMP / BZO / BAR / TCA / PCP
Catalog Number
6A269UL
Brand Name
Syva® RapidTest d.a.u.® 8
Version/Model Number
10445361
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983147,K983147
Product Code
DIO
Product Code Name
ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES
Public Device Record Key
98dee488-54b4-4abc-96cd-38f78c1b97d9
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 24, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |