Duns Number:098268311
Device Description: DOA 5 in 1 Test CRL QuickScreen Cup W/AD, 25Pcs/Box; Without Security Label & No Disposabl DOA 5 in 1 Test CRL QuickScreen Cup W/AD, 25Pcs/Box; Without Security Label & No Disposable GlovesCOC/mAMP/OPI/PCP/THC/PH-SG-OX CLIA waived
Catalog Number
KCUR920099
Brand Name
CRL Stat ™
Version/Model Number
KCUR920099
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
-
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
001e1006-8a0f-4159-98e3-21d091323510
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
October 14, 2016
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. | 18 |