Duns Number:064177324
Device Description: 13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, 13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip - 25 Pack Box.
Catalog Number
ID-H13-1
Brand Name
Identify Health Drug Testing Device Test Cups
Version/Model Number
ID-H13-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122809,K122809
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
fd160771-fe11-41d1-9961-7e1112957978
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
August 30, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |