FDA.reportPublic FDA data

Healgen

Primary DI
00810173655804
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDTH-114
Device description
K2406861 Panel Dip Card: THC MARIJUANA / CANNABINOIDS TEST, 50ng/ml
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810173655801PackageGS125In Commercial Distribution
20810173655808PackageGS120In Commercial Distribution
00810173655804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017365580110810173655801
2081017365580820810173655808
00810173655804008101736558048101736558040810173655804

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
7137338088Bryan.fang@healgen.com

Regulatory Flags#

DUNS number
031802328
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810173656177Healgen HCDOAF-2542026-05-08
00810173656399HealgenHCDOAV-2652026-05-08
00810173656405HealgenHDOA-1104C2026-05-08
00810173656412HealgenHDOA-1942026-05-08
00810173656429HealgenHDOA-2652026-05-08
00810173656139Healgen HCDOAEW-131042026-04-16
00810173656344HealgenHCDOAEW-21352026-04-16
00810173656351HealgenHCDOAEW-41042026-04-16
00810173655118HealgenHCDOAEW-61252026-04-15
00810173655774Healgen HCDOAB-385T3AD2026-04-15
00810173655781HealgenHDOA-51252026-04-15
00810173655798HealgenHDOA-5352026-04-15
00810173655897Healgen HCDOAV-10115A32026-04-15
00810173655903HealgenHCDOAV-975A32026-04-15
00810173656184Healgen HCDOAF-61242026-04-03
00810173656191HealgenHCDOAF-81042026-04-03
00810173656207HealgenHCDOAV-1542026-04-03
00810173656214HealgenHCDOAV-71052026-04-03
00810173656221HealgenHDOA-2552026-04-03
00810173656238HealgenHDOA-41052026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066008369Rapid ResponseBTNX IncLDJ2024-02-26
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncLDJ2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10722066005139Rapid ResponseBTNX IncLDJ2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10763924935632Accutest JANT PHARMACAL CORPORATIONLDJ2019-03-05
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-12
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-12-05
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-07-05
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-06-20
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncLDJ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncLDJ2018-05-21
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-03-14
10694644500384RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-03-14
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
10694644500278RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2017-10-06