Smart DetectTM SARS-CoV-2 rRT-PCR Kit

GUDID B379COV2E0

EUA

INBIOS INTERNATIONAL, INC

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device IDB379COV2E0
NIH Device Record Key03a9877d-4b9b-486b-b4ba-74490a3919c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart DetectTM SARS-CoV-2 rRT-PCR Kit
Version Model NumberCOV2-E
Company DUNS004006628
Company NameINBIOS INTERNATIONAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB379COV2E0 [Primary]

FDA Product Code

QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-23
Device Publish Date2020-07-15

Devices Manufactured by INBIOS INTERNATIONAL, INC

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B379COV2E0 - Smart DetectTM SARS-CoV-2 rRT-PCR Kit2020-07-23EUA
B379COV2E0 - Smart DetectTM SARS-CoV-2 rRT-PCR Kit2020-07-23 EUA
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