Duns Number:010964864
Device Description: LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphet LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml
Catalog Number
-
Brand Name
LifeSign QuikScreen 11
Version/Model Number
60B02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2016
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071489,K071489,K071489
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
8300f52e-0d02-4ace-9b70-b0771deec64e
Public Version Date
March 26, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20863480002100
Quantity per Package
4
Contains DI Package
10863480002103
Package Discontinue Date
February 01, 2013
Package Status
Not in Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |