FDA.reportPublic FDA data

Healgen

Primary DI
20816490020282
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDOX-201
Catalog number
HDOX-201
Device description
Single Panel DOA Test Cassette
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
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816490020285PackageGS125In Commercial Distribution
20816490020282PackageGS120In Commercial Distribution
00816490020288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002028510816490020285
2081649002028220816490020282
00816490020288008164900202888164900202880816490020288

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
10810173655931HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655955HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655047HealgenHealgen Scientific Limited Liability CompanyLFG2026-02-04
10810173655689HealgenHealgen Scientific Limited Liability CompanyLFG2026-02-04
10810173655610HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655672Healgen Healgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655696HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655702HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655719HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
00810173654937HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-08
10810173654521Healgen Healgen Scientific Limited Liability CompanyLFG2025-12-19
10810173654545HealgenHealgen Scientific Limited Liability CompanyLFG2025-12-19
10810173654651HealgenHealgen Scientific Limited Liability CompanyLFG2025-12-19
10815845023797SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LFG2024-12-17
10810124273085SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)ALERE SAN DIEGO, INC.LFG2023-12-15
00690286000780PROFILE-II ER®MEDTOX DIAGNOSTICS, INC.LFG2023-06-01
30817405022442iScreen™Instant Technologies, Inc.LFG2023-02-07
00869419000243Express ResultsTM Quest DiagnosticsLFG2022-03-28
20612479255306McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
20612479255337McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
20612479258444McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10816862021780PreviewWONDFO USA CO., LTD.LFG2019-12-22
20817038021631UCP Home Drug Screening Test CupsUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021730UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021778UCP Drug Test Mini Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021815u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021860u-Cup Drug Test ScreenUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021891UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
00895330002790Healgen (Private Label) - 3124CONFIRM BIOSCIENCES, INC.LFG2016-11-15
20817038021136u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2016-10-24