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
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03