FDA.reportPublic FDA data

GenBody COVID-19 Ag Home Test

Primary DI
08800076701410
Brand
GenBody COVID-19 Ag Home Test
Company
Genbody Inc.
Model
COVAGHT2-U-2
Catalog number
COVAGHT2-U-02
Device description
The GenBody COVID-19 Ag Home Test is a manually performed and visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 when tested at least twice over three (3) days with at least 48 hours between tests. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged two (2) years or older.
Published
2026-10-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251916000GenBody COVID-19 Ag Home TestGenbody.Inc.2026-03-13QYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076701410PrimaryGS10
08800076701427Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076701410088000767014108800076701410
08800076701427088000767014278800076701427

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), 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 intended to be used for self-testing by a layperson in the home or similar environment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
(888) 552-5204ts@genbodyamerica.com

Regulatory Flags#

DUNS number
689451998
Device count
2
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
true
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
08800076700222GenBody COVID-19 Ag Home TestCOVAGHT2-U-2COVAGHT2-U-022023-02-27
08800076700727GenBody COVID-19 Ag Home TestCOVAGHT2-U-5COVAGHT2-U-052023-02-27
08800076700734GenBody COVID-19 Ag Home TestCOVAGHT2-U-1COVAGHT2-U-012023-02-27
08800076700789GenBody COVID-19 AgCOVAG025-NU-1COVAG025-NU-12023-03-28
08800076700772GenBody COVID-19 AgCOVAG025-NU-1COVAG025-NU-12023-03-28
08800076700598GenBody COVID-19 Ag Home TestCOVAGHT2-U-25COVAGHT2-U-252023-02-27
08800076700741GenBody COVID-19 Ag Home TestCOVAGHT2-U-2COVAGHT2-U-22023-02-27
08800076700765GenBody COVID-19 Ag Home TestCOVAGHT2-U-25COVAGHT2-U-252023-02-27
08800076700758GenBody COVID-19 Ag Home TestCOVAGHT2-U-5COVAGHT2-U-52023-02-27
08800076700482GenBody COVID-19 AgCOVAG025-NUCOVAG025-NU2021-10-19
08800076700437GenBody COVID-19 AgCOVAG025-UCOVAG025-U2021-08-18
08800076700499GenBody COVID-19 AgCOVAG025-NUCOVAG025-NU2021-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010224480CareSuperb COVID-19 Antigen TestAccess Bio Inc.QYT2026-10-01
00311917080062WalgreensWALGREEN CO.QYT2026-08-26
50850078377369iHealthiHealth Labs Inc.QYT2026-07-21
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.QYT2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCQYT2026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00050428101735CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2025-08-08
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