Duns Number:251005005
Device Description: Rapid Response Multi-Drug One Step Cup - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 Rapid Response Multi-Drug One Step Cup - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 TCA1000
Catalog Number
-
Brand Name
Rapid Response
Version/Model Number
D12.21-1V
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180349
Product Code
NFT
Product Code Name
Test, Amphetamine, Over The Counter
Public Device Record Key
ddbaaf79-f09b-4f07-9cd6-10e1b1d70df2
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 22, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |