Duns Number:062312574
Device Description: 14 Drugs Test Kit - Marijuana (THC50), Cocaine (COC300), Methamphetamine (MET1000), Phency 14 Drugs Test Kit - Marijuana (THC50), Cocaine (COC300), Methamphetamine (MET1000), Phencyclidine (PCP25), Opiates (OPI2000), Amphetamine (AMP1000), Ecstasy (MDMA500), Tricyclic Antidepressants (TCA1000), Barbiturates (BAR300), Benzodiazepines (BZO300), Methadone (MTD300), Oxycodone (OXY300), Propoxyphene (PPX300), Buprenorphine (BUP10)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
346468
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
-
Product Code
NFT
Product Code Name
Test, Amphetamine, Over The Counter
Public Device Record Key
1af8b27a-739f-45bd-a1d4-b5a7a89c2c4f
Public Version Date
August 01, 2022
Public Version Number
4
DI Record Publish Date
December 03, 2020
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |