FDA.reportPublic FDA data

Healgen

Primary DI
00810173656252
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDTC-114
Device description
K2406861 Panel Dip Card; TCA Tricyclic AntiDepressants Test, 1000ng/ml
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
10810173656259PackageGS125In Commercial Distribution
20810173656256PackageGS120In Commercial Distribution
00810173656252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017365625910810173656259
2081017365625620810173656256
00810173656252008101736562528101736562520810173656252

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

Contacts#

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

Regulatory Flags#

DUNS number
031802328
Device count
1
Lot or batch
true
Expiration date on label
true

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
10850013035523Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035585Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035608Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850076289062Hysen Drug Test CupsHYSEN INC.LFG2026-03-18
10850076289000Hysen Drug Test CupsHYSEN INC.LFG2025-08-04
10850076289017Hysen Drug Test CardsHYSEN INC.LFG2025-08-04
10858886006848Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2025-01-17
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LFG2024-02-09
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LFG2023-11-30
10858886006824Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2023-10-20
10817038022174Number OneUCP BIOSCIENCES, INC.LFG2023-06-16
10850013035189Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2023-03-08
10858886006770Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2023-02-14
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.LFG2022-11-07
10850013035172Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2022-08-01
10858886006701Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-07-14
10858886006688Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-06-14
10858886006565Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006572Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006596Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
20869419000230Express ResultsTM Quest DiagnosticsLFG2022-03-28
20869419000247Express ResultsTM Quest DiagnosticsLFG2022-03-28
30869419000237Express ResultsTM Quest DiagnosticsLFG2022-03-28
10817815020683CRL Stat Dip CardW.H.P.M. INC.LFG2021-08-25
10796918002423INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.LFG2021-07-29
10796918002201INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.LFG2021-04-21
10796918002195INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.LFG2020-09-14
10817405021311iScreen™Instant Technologies, Inc.LFG2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LFG2020-08-21
10817038022037UCP Compact Drug Test CassetteUCP BIOSCIENCES, INC.LFG2020-06-24