FDA.reportPublic FDA data

Healgen

Primary DI
20816490020374
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDOA-134
Catalog number
HDOA-134
Device description
3 Panel DOA Test Dipcard
Published
2017-02-18
Public version status
Update
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
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816490020377PackageGS125In Commercial Distribution
20816490020374PackageGS120In Commercial Distribution
00816490020370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002037710816490020377
2081649002037420816490020374
00816490020370008164900203708164900203700816490020370

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
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7137338088bryan@healgen.com

Regulatory Flags#

DUNS number
031802328
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00810173656221HealgenHDOA-2552026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDJR2021-06-24
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDJR2019-03-11
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2019-02-12
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2018-03-30
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONDJR2017-10-10
10694644500278RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500285RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500292RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500308RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500315RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500322RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500254RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-08-02
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-06-29
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2017-06-08
10694644500247RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-05-31
10694644400660INCUPAMERICAN BIO MEDICA CORPORATIONDJR2017-05-05
10694644500230RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-04-25
10694644400653INCUPAMERICAN BIO MEDICA CORPORATIONDJR2017-03-21