FDA.reportPublic FDA data

Healgen

Primary DI
20816490021265
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
GAHCG-105a
Catalog number
GAHCG-105a
Device description
hCG women pregnancy Test (Urine, 25mIU/ml)
Published
2017-04-06
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
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816490021268PackageGS125In Commercial Distribution
20816490021265PackageGS120In Commercial Distribution
00816490021261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002126810816490021268
2081649002126520816490021265
00816490021261008164900212618164900212610816490021261

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit (beta-HCG) 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 beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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
00810164510006ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510019ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510026ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510033ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510040ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510057ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510064ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510112Atida Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510129Atida Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510150Atida Digital Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510693Atida Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510709Atida DIGITAL EARLY PREGNANCY TESTACESO LABORATORIES INC.LCX2026-03-23
00812203030889ChemtrueCHEMTRON BIOTECH INCLCX2026-03-10
00072036704283Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036714299Harris TeeterHarris Teeter, LLCLCX2026-02-27
30075450847636Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847642Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847659Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
30075450847667Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
30075450847674Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
10751774000037DG HealthDOLGENCORP, LLCLCX2026-02-20
10311917083800WalgreensWALGREEN CO.LCX2026-02-17
10311917083954WalgreensWALGREEN CO.LCX2026-02-17
10311917084029WalgreensWALGREEN CO.LCX2026-02-17
00070552251120Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00070552351134Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
10311917083459WalgreensWALGREEN CO.LCX2026-02-05
10311917083510WalgreensWALGREEN CO.LCX2026-02-05
10311917083572WalgreensWALGREEN CO.LCX2026-02-05
50045611010005SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28