Duns Number:966665036
Device Description: RTC II cup with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA in BulkRTC II 1st Generation with SV RTC II cup with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA in BulkRTC II 1st Generation with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA
Catalog Number
10-8MZX2AB-030
Brand Name
RTCII 1st gen.
Version/Model Number
10-8MZX2AB-030
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073078,K073078
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
5cf7fb9b-68d3-43bf-879e-6449a599bc78
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 19, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |