Duns Number:019410187
Device Description: iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MOP300/OXY100/PCP25/THC50)+ SVT Cr, pH, S.G.
Catalog Number
ABTDUAW110704D
Brand Name
iScreen™
Version/Model Number
ABTDUAW110704D
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
K182701,K182701,K182701
Product Code
LCM
Product Code Name
Enzyme Immunoassay, Phencyclidine
Public Device Record Key
d801cbd5-dbd1-467c-ad37-716d6d38806e
Public Version Date
October 31, 2022
Public Version Number
2
DI Record Publish Date
June 16, 2022
Package DI Number
30817405022220
Quantity per Package
4
Contains DI Package
00817405022229
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| 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. | 122 |
| U | Unclassified | 1 |