FDA.reportPublic FDA data

LifeSign QuikScreen 11

Primary DI
20863480002100
Brand
LifeSign QuikScreen 11
Company
Lifesign L.L.C.
Model
60B02
Device description
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
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071489000HOMECHECK MULTIPLE DRUG CUP TESTTianjin New Bay Bioresearch Co., Ltd.2008-03-28DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10863480002103PackageGS125Not in Commercial Distribution
20863480002100PackageGS14Not in Commercial Distribution
00863480002106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086348000210310863480002103
2086348000210020863480002100
00863480002106008634800021068634800021060863480002106

GMDN Terms#

Term, Definition table
TermDefinition
Drug/toxicology adulteration IVD, kit, enzyme spectrophotometry, rapidA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010964864
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863480002106LifeSign QuikScreen 1160B022016-09-24
00863480002113Status Toxi Cup 13+465C12+42016-09-24
00868348000256Status Toxi Cup65C13+42017-05-17
00868348000201Status ASSURE 11125AA11125AA2016-09-01
00868348000218Status ASSURE11125AA2K11125AA2K2016-09-01
00868348000225Status ASSURE71125AA71125AA2016-09-01
00868348000232Status ASSURE71125AA2K71125AA2K2016-09-01
00868348000249Status ASSURE76025AA2K76025AA2K2016-09-01
20863480002117Status Toxi Cup 13+465C12+42016-09-24
10868348000253Status Toxi Cup65C13+42017-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJG2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-07-05