FDA.reportPublic FDA data

Healgen

Primary DI
20816490020503
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDOA-655
Catalog number
HDOA-655
Device description
5 Panel DOA Test Dipcard
Published
2017-02-20
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816490020506PackageGS125In Commercial Distribution
20816490020503PackageGS120In Commercial Distribution
00816490020509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002050610816490020506
2081649002050320816490020503
00816490020509008164900205098164900205090816490020509

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
10810173655962HealgenHealgen Scientific Limited Liability CompanyLCM2026-03-11
10810173655566HealgenHealgen Scientific Limited Liability CompanyLCM2026-02-04
00810173654920HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
00810173655071HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173655085HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173654774HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
10810173654798HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
00812101031599ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031605ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031612ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031995ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
10810173654538Healgen Healgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654576HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654637HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
08500130357170Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035809Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035878Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035076Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-09-11
10816862026785Prime ScreenWONDFO USA CO., LTD.LCM2025-07-03
10816862026358SAFElife™WONDFO USA CO., LTD.LCM2024-12-24
10815845023162SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LCM2024-12-17
00817763022510First Sign®HEMOSURE INC.LCM2024-10-16
00812203030780DrugSmart CupCHEMTRON BIOTECH INCLCM2024-07-29
10810124273245SureStepTM Urine Test Drug Screen Strip, Phencyclidine (PCP 25)ALERE SAN DIEGO, INC.LCM2023-12-15
00858886006827Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLCM2023-10-20
00817815021119CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.LCM2023-08-23
10690286000763PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.LCM2023-08-01
30817405023821iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405023883iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405021711iScreen™Instant Technologies, Inc.LCM2023-02-07