DEVICE: LifeSign QuikScreen 11 (00863480002106)

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Device Identifier (DI) Information

LifeSign QuikScreen 11
60B02

Lifesign L.L.C.
00863480002106
GS1
1
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Drug/toxicology adulteration IVD, kit, enzyme spectrophotometry, rapid A collection of reagents and other associated materials intended to be used for the qualitative detection of drug and/or toxicology adulteration of a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

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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
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20863480002100 4 10863480002103 In Commercial Distribution Shipper Box
10863480002103 25 00863480002106 In Commercial Distribution Kit Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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