FDA.reportPublic FDA data

Healgen

Primary DI
10810173655931
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HCDOAEW-6125SA3
Device description
K243365 12 Panel Cup Type #31 with Low Cutoff and A3: AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MTD300, OXY100, PCP25, THC50, +(OXI/SG/pH)
Published
2026-03-11
Public version status
New
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
10810173655931PackageGS125In Commercial Distribution
20810173655938PackageGS14In Commercial Distribution
00810173655934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017365593110810173655931
2081017365593820810173655938
00810173655934008101736559348101736559340810173655934

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
031802328
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00810173656726HealgenHCDOAV-1145SA52026-06-03
00810173656733HealgenHCDOAV-154A32026-06-03
00810173656740HealgenHCDOAV-2145A32026-06-03
00810173656757HealgenHCDOAV-274A32026-06-03
00810173656764HealgenHCDOAV-41042026-06-03
00810173656771HealgenHDOA-1442026-06-03
00810173656788HealgenHDOA-1842026-06-03
00810173656702AccurateHCDOAF-22105SA32026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLFG2026-06-02
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