FDA.reportPublic FDA data

Healgen

Primary DI
20816490021098
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDOA-1124A3
Catalog number
HDOA-1124A3
Device description
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Published
2016-12-31
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
JXNEnzyme Immunoassay, Propoxyphene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816490021091PackageGS125In Commercial Distribution
20816490021098PackageGS120In Commercial Distribution
00816490021094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002109110816490021091
2081649002109820816490021098
00816490021094008164900210948164900210940816490021094

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
00810173655927HealgenHCDOAEW-6125A32026-03-11
10810173655931HealgenHCDOAEW-6125SA32026-03-11
10810173655948HealgenHCDOAV-5125SF72026-03-11
10810173655955HealgenHCDOAV-5642026-03-11
10810173655962HealgenHCDOAV-6125A3A2026-03-11
10810173655979HealgenHCDOAV-8552026-03-11
10810173655986HealgenHDMO-1142026-03-11
10810173655993HealgenHDOA-11442026-03-11
10810173656006HealgenHDOA-1242026-03-11
10810173656013HealgenHDOA-2342026-03-11
10810173656020HealgenHDOA-31242026-03-11
10810173656037HealgenHDOX-1142026-03-11
10810173655047HealgenHDOA-2542026-02-04
00810173655507Healgen HCDOAV-51252026-02-04
10810173655566HealgenHCDOAF-6125A3C2026-02-04
10810173655580HealgenHCDOAV-1642026-02-04
10810173655597HealgenHCDOAV-2542026-02-04
10810173655658HealgenHCDOAV-81042026-02-04
10810173655689HealgenHDOA-2642026-02-04
00810173654920HealgenHDOA-11242026-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810124273672SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.JXN2024-09-17
00841824105034N/AW.H.P.M. INC.JXN2023-02-14
00869419000236Express ResultsTM Quest DiagnosticsJXN2022-03-28
00841824104853NAW.H.P.M. INC.JXN2021-10-12
10694644450740INCUPAMERICAN BIO MEDICA CORPORATIONJXN2021-06-24
00816036027160STATCUP® MICRO DISTRIBUTING, L.CJXN2021-01-14
00811727017918Pointe Propoxyphene (PPX) Reagent SetPOINTE SCIENTIFIC, INC.JXN2020-09-25
00811727017925Pointe Propoxyphene (PPX) Reagent SetPOINTE SCIENTIFIC, INC.JXN2020-09-25
10694644150459Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2020-05-29
07613336166116Propoxyphene PlusRoche Diagnostics GmbHJXN2020-03-05
00841824101920ECO® II CupW.H.P.M. INC.JXN2020-01-17
00380740165307AlinityABBOTT LABORATORIESJXN2019-10-10
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2019-10-03
00850798007787CSITRANSMED CO, LLCJXN2019-10-01
20816490022941HealgenHealgen Scientific Limited Liability CompanyJXN2019-07-31
20816490022866HealgenHealgen Scientific Limited Liability CompanyJXN2019-07-29
00841824104334ECO® II CupW.H.P.M. INC.JXN2019-07-10
00816036026569STATCUP® MICRO DISTRIBUTING, L.CJXN2019-07-02
00812203030148GenericCHEMTRON BIOTECH INCJXN2019-04-29
00817763022428FIRST SIGN®HEMOSURE INC.JXN2019-04-29
20850721007888Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCJXN2019-04-18
00817815020259CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.JXN2019-03-18
00858886006322Noble 1 Step CupNOBLE MEDICAL INCJXN2019-01-24
00855944007383Easy@Home 9 Panel Instant Urine Drug Test (2 test kit)EASY HEALTHCARE CORPORATIONJXN2018-06-26
20816490021883HealgenHealgen Scientific Limited Liability CompanyJXN2018-04-24
00851950008154ArvolifeClinical GuardJXN2018-03-26
00630414595948Atellica CH PpxSiemens Healthcare Diagnostics Inc.JXN2017-12-22
00816036025623STATDIP®MICRO DISTRIBUTING, L.CJXN2017-12-04
00816036025920STATDIP®MICRO DISTRIBUTING, L.CJXN2017-12-04
20612479215393McKessonMCKESSON MEDICAL-SURGICAL INC.JXN2017-08-02