FDA.reportPublic FDA data

OHC COVID-19 Antigen Self Test

Primary DI
08809115904621
Brand
OHC COVID-19 Antigen Self Test
Company
OSANG HEALTHCARE Co., Ltd.
Model
OI-01SA-SH
Catalog number
FBE00608
Device description
2 Test Kit / Box
Published
2022-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809115904621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809115904621088091159046218809115904621

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 Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-760-0556covidhometest@osangllc.com

Regulatory Flags#

DUNS number
688195374
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809115905796Oh'care Lite Smart Glucose Test StripIGM-1003F2020-11-05
08809115908438Element™ Test StripsIGM-0021B2017-12-11
08809115908957Element™Plus Test StripsIGM-0021B2017-07-21
08809115905369OKRA Glucose Test Strip(25T)IGM-1003A2021-07-27
08809115905697OKRA Glucose Test Strip Refill kitIGM-1003A2020-10-29
08809115905710OKRA Glucose Test StripIGM-1003A2020-10-29
08809115906540Oh'Care Lite Smart Glucose Test StripIGM-1003F2019-09-17
00793150629787Oh’Care Lite Blood Glucose Test stripsIGM-1003AINFS003L2017-11-03
08809115900449QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC02ENA12025-03-18
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOI-01SQ-C1RCQC110ENA12025-03-12
08809115900418QuickFinder™ COVID-19/Flu Antigen ProTestOI-01SU-CCRCUCC25ENP12025-03-18
08809115900425QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC05ENA12025-03-18
08809115900432QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC04ENA12025-03-18
08809115900456QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC01ENA12025-03-17
08809115904119CURO L5 Glucose test stripILM-0001AINFSG001EF2022-09-26
08809115905406CURO L5 MeterILM-0001A2021-07-09
08809115905413CURO L5 TC test stripILM-0001A2021-07-09
08809115905444CURO L5 TG test stripILM-0001A2021-06-17
08809115905703OKRA Glucose monitoring system starter kitIGM-1003A2020-10-29
08809115905727OKRA Glucose meterIGM-1003A2020-10-29