OHC COVID-19 Antigen Self Test FBE00626

GUDID 08809115904614

4 Test Kit / Box

OSANG HEALTHCARE Co., Ltd.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Primary Device ID08809115904614
NIH Device Record Key937f06a9-784c-441b-acff-85d07e13fb9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOHC COVID-19 Antigen Self Test
Version Model NumberOI-01SA-SH
Catalog NumberFBE00626
Company DUNS688195374
Company NameOSANG HEALTHCARE Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com
Phone1-844-760-0556
Emailcovidhometest@osangllc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108809115904614 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-29
Device Publish Date2022-06-21

On-Brand Devices [OHC COVID-19 Antigen Self Test]

088091159046451 Test Kit / Box
088091159046212 Test Kit / Box
088091159046144 Test Kit / Box
088091159046075 Test Kit / Box
0880911590459125 Test Kit / Box

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.