FDA.reportPublic FDA data

Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit

Primary DI
06921963715258
Brand
Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit
Company
Xiamen Boson Biotech Co., Ltd.
Model
1N40C5-8-US
Device description
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Published
2022-09-24
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
QKPCoronavirus Antigen Detection Test System.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKPCoronavirus Antigen Detection Test System.UnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16921963712957PackageGS16In Commercial Distribution
06921963712516PrimaryGS10
06921963712523PrimaryGS10
06921963712929PrimaryGS10
06921963712936PrimaryGS10
06921963712943PrimaryGS10
06921963712950PrimaryGS10
06921963715296PrimaryGS10
06921963715258Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692196371295716921963712957
06921963712516069219637125166921963712516
06921963712523069219637125236921963712523
06921963712929069219637129296921963712929
06921963712936069219637129366921963712936
06921963712943069219637129436921963712943
06921963712950069219637129506921963712950
06921963715296069219637152966921963715296
06921963715258069219637152586921963715258

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
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-800-689-7794support@bosoncovt.com

Regulatory Flags#

DUNS number
527409818
Device count
8
DM exempt
false
Premarket exempt
true
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
06921963715296Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit1N40C5-2-US2022-11-08
06921963712516Boson - Rapid SARS-CoV-2 Antigen Test Card - 5 Tests/Kit1N40C5-5-US2022-10-08
06921963712523Boson - Rapid SARS-CoV-2 Antigen Test Card - 20 Tests/Kit1N40C5-20-US2022-10-08
06921963712936Boson - Rapid SARS-CoV-2 Antigen Test Card - 40 Tests/Kit1N40C5-40-US2022-10-08
06921963712943Boson - Rapid SARS-CoV-2 Antigen Test Card - 10 Tests/Kit1N40C5-10-US2022-10-08
06921963712950Boson - Rapid SARS-CoV-2 Antigen Test Card - 4 Tests/Kit1N40C5-4-US2022-10-08
06921963712493Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit1N40C5-1-US2022-10-08
06921963712929Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit1N40C5-8-US2022-09-24
06921963712509Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit1N40C5-2-US2022-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013635107Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635114Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635121Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
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10816862024606WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
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00742860000089OSOM Flu SARS-CoV-2 Combo HomeSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
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00810172700086Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08
10810172700083RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
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20810172700080RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
20810172700097RDB10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2024-08-08
30810172700087CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08
30810172700094CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)WatMIND USAQKP2024-08-08
40810172700084CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08