Duns Number:098268311
Device Description: DOA 5 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/BoxCOC300 MET1000 OPI2000 PCP25 THC50
Catalog Number
-
Brand Name
CRL STAT Cup
Version/Model Number
KCUR920074
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)
Yes
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
fa0beba0-526c-4681-a46b-ed8149596f8a
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
March 15, 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. | 18 |