FDA.reportPublic FDA data

ZeroChaos

Primary DI
B539605053ZC0
Brand
ZeroChaos
Company
Zerochaos
Model
60505-3 ZC
Catalog number
60505-3 ZC
Device description
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Published
2017-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B539605053ZC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
173064457
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B539605053ZC10ZeroChaos60505-3 ZC60505-3 ZC2019-04-17
B539609673ZC10ZeroChaos60967-3-ZC60967-3-ZC2019-04-17
B539610203ZC10ZeroChaos61020-3 ZC61020-3 ZC2019-04-17
B53960505ZC0Zero Chaos60505 ZC60505 ZC2017-06-19
B539609673ZC0ZeroChaos60967-3-ZC60967-3-ZC2018-04-27
B539610203ZC0Zero Chaos61020-3 ZC61020-3 ZC2017-06-19
B53961020ZC0Zero Chaos61020 ZC61020 ZC2017-06-19
B539611133ZC0Zero Chaos61113-3 ZC61113-3 ZC2017-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2017-06-08