FDA.reportPublic FDA data

Healgen

Primary DI
20816490021371
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HCDOAF-654
Catalog number
HCDOAF-654
Device description
5 Panel DOA Test Clear Flat Cup
Published
2017-05-04
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
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
10816490021374PackageGS125In Commercial Distribution
20816490021371PackageGS14In Commercial Distribution
00816490021377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002137410816490021374
2081649002137120816490021371
00816490021377008164900213778164900213770816490021377

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
00810173655927HealgenHealgen Scientific Limited Liability CompanyDIO2026-03-11
10810173656006HealgenHealgen Scientific Limited Liability CompanyDIO2026-03-11
10810173656013HealgenHealgen Scientific Limited Liability CompanyDIO2026-03-11
10810173655573HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-30
10810173655733HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-30
00810173654784HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-08
10810173655092HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-08
10810173654590HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
10810173654606HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
10810173654620HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
00850013035755Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-12-04
00850013035854Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-12-04
00850721007679Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-09-11
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10810124273849CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273856CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273863CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273870CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10815845023148SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DIO2024-12-17
00850013036004Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2024-11-20
06972412618569LyherHangzhou Laihe Biotech Co.,Ltd.DIO2024-11-12
10810124272972CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273795CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273801CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273818CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273825CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124274518CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273146SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DIO2024-09-17
10810124273566SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DIO2024-09-17
10810124273573SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DIO2024-09-17