FDA.reportPublic FDA data

Healgen

Primary DI
10810173656006
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDOA-124
Device description
K240686 2 Panel DOA Test Dip card: COC300, THC50
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810173656006PackageGS125In Commercial Distribution
20810173656003PackageGS120In Commercial Distribution
00810173656009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017365600610810173656006
2081017365600320810173656003
00810173656009008101736560098101736560090810173656009

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
031802328
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
00810173656702AccurateHCDOAF-22105SA32026-06-02
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
00810173655804HealgenHDTH-1142026-04-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDIO2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30