FDA.reportPublic FDA data

Healgen

Primary DI
10810173651230
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
GCFC-525SKa-H1
Device description
Healgen COVID-19 FLU A/B Combo De Novo Test
Published
2025-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
SCAMulti-Analyte Respiratory Virus Antigen Detection Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCAMulti-Analyte Respiratory Virus Antigen Detection TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240029000Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen2024-10-07SCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810173651230PackageGS11In Commercial Distribution
20810173651237PackageGS1360In Commercial Distribution
00810173651233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017365123010810173651230
2081017365123720810173651237
00810173651233008101736512338101736512330810173651233

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Sterilization Methods#

Method table
Method

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
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
00850010224442CareSuperb COVID-19/FluA&B Antigen Combo TestAccess Bio Inc.SCA2026-06-08
00850078377180iHealthiHealth Labs Inc.SCA2026-05-15
00850078377272iHealthiHealth Labs Inc.SCA2026-05-15
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00311917077598WalgreensWALGREEN CO.SCA2026-04-28
00050428373927CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDSCA2026-04-27
00840733101557statID Pro COVID-19/Flu External ControlsMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00840733101564statID Pro COVID-19/Flu A&BMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
00850078377227iHealthiHealth Labs Inc.SCA2026-01-30
00810107290033Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
10850078377224iHealthIHEALTH LAB INC.SCA2026-01-30
10197344173587MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
20197344173584MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
00895160002960Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
00850078377098iHealthiHealth Labs Inc.SCA2026-01-02
00850078377104iHealthiHealth Labs Inc.SCA2026-01-02
00850078377128iHealthiHealth Labs Inc.SCA2026-01-02
00850078377135iHealthiHealth Labs Inc.SCA2026-01-02
10850078377095iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377101iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377125iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377132iHealthIHEALTH LAB INC.SCA2026-01-02
00850010224381CareSuperb COVID-19/FluA&B Antigen Combo Home TestAccess Bio Inc.SCA2025-12-24
10612479277936McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
40612479277944McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
00810107290224Flowflex Plus RSV + Flu A/B + COVID Home TestAcon Laboratories, Inc.SCA2025-11-06
30014613340751QuickVue™ WONDFO USA CO., LTD.SCA2025-10-31