DEVICE: LifeSign QuikScreen 11 (00863480002106)
Device Identifier (DI) Information
LifeSign QuikScreen 11
60B02
Not in Commercial Distribution
Lifesign L.L.C.
60B02
Not in Commercial Distribution
Lifesign L.L.C.
LifeSign QuikScreen 11:
Amphetamine (AMP) 1000 ng/ml
Phencyclidine (PCP) 25 ng/ml
Methamphetamine (MET) 1000 ng/ml
Opiate (OPI) 2000 ng/ml
Barbiturates (BAR) 300 ng/ml
Benzodiazepine (BZD) 300 ng/ml
Marijuana (THC) 50 ng/ml
Methadone (MAD) 300 ng/ml
Oxycodone (OXY) 100 ng/ml
Tricyclic Antidepressants (TCA) 1000 ng/ml
Cocaine (COC) 300ng/ml
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
55463 | Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DJG | Enzyme Immunoassay, Opiates |
LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs |
DJR | Enzyme Immunoassay, Methadone |
DJC | Thin Layer Chromatography, Methamphetamine |
LDJ | Enzyme Immunoassay, Cannabinoids |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
JXM | Enzyme Immunoassay, Benzodiazepine |
DIS | Enzyme Immunoassay, Barbiturate |
DKZ | Enzyme Immunoassay, Amphetamine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K071489 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8300f52e-0d02-4ace-9b70-b0771deec64e
July 06, 2023
6
September 24, 2016
July 06, 2023
6
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20863480002100 | 4 | 10863480002103 | 2013-02-01 | Not in Commercial Distribution | Shipper Box |
10863480002103 | 25 | 00863480002106 | 2013-02-01 | Not in Commercial Distribution | Kit Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined