Primary Device ID | 08800076700437 |
NIH Device Record Key | 9b52759b-14ce-43ac-b456-00eb8610ead4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GenBody COVID-19 Ag |
Version Model Number | COVAG025-U |
Catalog Number | COVAG025-U |
Company DUNS | 689451998 |
Company Name | Genbody Inc. |
Device Count | 25 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | true |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr | |
Phone | +821062090401 |
jychoi@genbody.co.kr |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800076700437 [Primary] |
GS1 | 08800076700475 [Unit of Use] |
QKP | Coronavirus Antigen Detection Test System. |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-26 |
Device Publish Date | 2021-08-18 |
08800076700437 | Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal sw |
08800076700499 | Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab sp |
08800076700772 | Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab sp |